Medtronic

I am rejecting this response because: I have had no contact from Medtronic regarding this issue, there is NO PATIENT EDUCATION provided on the device in question PRIOR to INSERTION of this device! I have received multiple stories on this item from the Customer Service reps VS the Cardiologists, no one knows what is the correct process or time limit that is safe post battery expirationAlso, I have been informed that there have been NO CLINICAL STUDIES to look a the long term effects of leaving this device inserted AFTER the battery is no longer running!!

Final Consumer Response / [redacted] (2000, 6, 2015/08/12) */ Ryan SAt Medtronic gave me a "courtesy discount of 20%" that got the amount due to within $of what I show I owedI consider this case closedThank you

Spoke with Jackie a manager in customer service and she said that the product has been shipped and received and this case is resolved in their system

Initial Business Response / [redacted] (1000, 5, 2015/05/22) */ Thank you for contacting the RevDex.com regarding your situation with the trial stimulation system. We are sorry to learn about your experience as you described in your original complaint. We would like to be of assistance and... would like to talk to you further about this situation. Please contact Medtronic Neuromodulation Patient Services at [redacted] and ask for Patient Relations. Initial Consumer Rebuttal / [redacted] (3000, 7, 2015/05/26) */ (The consumer indicated he/she DID NOT accept the response from the business.) I have not received any remedy but an apology and information about a "Patient Advocate Foundation" so I receive assistance with co-payments. About the issues developed due to the defective stimulation programmer it seems it has vanished from the clinic at KP. I was advised by my pain management doctor Medtronics rep have control on these units. Today Medtronics told me otherwise and also was advised there is no warranty on the 7-day trial, meaning anything that happens to one person including death one is responsible because one signs a consent for treatment. Then why don't they tell people or post this information clearly so people better understand the risks. I signed this consent seconds before going into the operating room, and I was already half sedated. They had forgotten to have me signed this before. This is very unprofessional and it's senseless that in such risky procedures there is no factory warranty. I inquired about this and there is indeed patients rights that protect us, but it seems Medtronics is not willing to accept responsibility even as I was provided with a faulty unit, so they say I now have to live like this. This is totally unethical and unacceptable and should be reported to the FDA. The model in question is the Medtronic MyStim model # 97740. Different codes were received and reported to the nurse in charge of the trial but until today no answers were received. Final Consumer Response / [redacted] (3000, 12, 2015/06/08) */ (The consumer indicated he/she DID NOT accept the response from the business.) Patient Relations consultant has not been able to assist and was instructed to go back to my treating physician. Today he called me and advised all he can do is treat the symptoms caused by the spinal cord stimulation failure, but that is it. Now I have to go back to Medtronic and ask again. It seems at this points no side is willing to take responsibility. Final Business Response / [redacted] (4000, 15, 2015/06/18) */ We have answered the consumer's questions regarding the product, and have also reviewed the product's labeling and warranty with him. The information the consumer provided does not indicate a problem with the device. We are sorry to hear about the patient's experience, however, the concerns he raises are medical in nature and need to be addressed by his physician. Thank you for taking the time to address your concerns.

Dear Mr***, I am following up, as promised, with a status update regarding a complaint with an assigned ID of *** The customer placed an order in September for a new pump and suppliesThe customer did qualify for Financial Assistance This assistance covers up to
90% of the customer’s out of pocket responsibility for the new pump, supplies and sensors up to a maximum benefit amount of $per order, for a total benefit amount of $1,per yearThe customer’s insurance plan does carry a high yearly deductible that had not been met when the order was placed, thus contributing to a higher out of pocket for the new pump and supplies We are willing to consider writing off the most recent supply order, and we would like to work with the customer to customize their supply orders that will help maximize the financial assistance benefit, as well as, reduce the customer’s out of pocket responsibility Medtronic Diabetes has made four attempts to reach the customer via telephone and email with the information on file in our systemAs of June 16, 2016, Medtronic Diabetes has not received a returned call or email from the customerMedtronic Diabetes does regret any inconvenience the customer has experienced, and we would like to work with the customer to resolve this matter Please let me know if this information is sufficient enough for a response, or if we should continue to reach out to the customer and keep this matter open until a specified dateI am available via email or phone if you should like to discuss the particulars of this investigation Thank you, Brenna ***

Final Consumer Response /* (2000, 6, 2015/12/07) */
The complaint has been resolved to my satisfaction

Customer Complaint: We received a Revdex.com complaint from customer’s mom regarding the FA programShe states she was advised that she was approved for 90% coverage of the out of pocket expense, however, she was not advised that there was a “limit” of $per order, for a max benefit of $1, Findings: Customer’s April order included infusion sets, reservoirs and sensors and had patient responsibility of before the $credit was applied for FAThis left a balance of Ideally, the out of pocket expense would not be this high, however, this was the first order of and a large amount was applied to Customer’s deductible Immediate Remedial Actions: A return was processed for the April order prior to the Revdex.com complaint being received and that order has been received back in house and the appropriate credits applied to the accountSeveral calls were made to MrsBaccaro to discuss next steps, however we have been unable to reach her by phoneShe did call and leave a message for me on Saturday 06/11/Her message did state that she submitted the Revdex.com complaint before she was offered a resolution and attempted to cancel the complaint, but was unsuccessfulWe have sent a letter indicating we would still like to discuss her experience in more detail and provide suggestions for future use of the FA program Long Term Resolution: In our letter we have advised MrsBaccaro we’d like to discuss the best way to utilize the FA benefits, including a breakdown of how the benefits are applied and the best way to place orders to get more use of the FA programAt this time, this request is considered closed until we hear back from MrsBaccaro

I am rejecting this response because:I dont like the way Medtronics changes my words. I said I tried to cancel the complaint, but it was already submitted. At this point everything I was told that day, before I was told to return two months worth of supplies it not what they are now telling you. I will try after work to contact them and find out why one department never knows what the other departments are saying or doing. I also want to know why no one there even asked what the email said from the first complaint, explaining to me, by one of their reps how the FA works. there was no talk of limit, at all. do they reasonably think that anyone has $extra dollars per month to pay for supplies, if that was told to me I would not have put the money out of my pocket from the beginning, because obviously I cant afford to have my daughter use it. I will let you know what they say after I speak to someone, and then you can run it by them to see if it is the truth or if they are going to change what I was told again. I do not feel comfortable agreeing to anything, since I dont have anything in writing from them. I also have not been sent a revised bill to pay for the two months worth of supplies that were returned, or are they going to send them back to me for free, like they told you the first time they made an offer to correct this problem, because no one ever told me that, they told you that

Medtronic has inquired into the patient’s complaint As a medical device manufacturer, Medtronic takes patient dissatisfaction with its products very seriously. However, Medtronic does not sell or prescribe the LINQ products directly to patients Treating physicians, in
consultation with their patients, use their medical judgment to determine whether implanting a LINQ device is appropriate for a given patient. The complainant has been in contact with Medtronic Patient Services, and Medtronic believes it has appropriately responded directly to his requests. However, in response to this Revdex.com complaint, Medtronic is also providing information, responsive to the complainant’s concerns, to his treating physician who may also wish to further address his concerns in the clinical setting Medtronic appreciates the opportunity to respond to this complaint, and would encourage the complainant to follow up further with his physician

Initial Business Response /* (1000, 5, 2015/05/22) */
Thank you for contacting the Revdex.com regarding your situation with the trial stimulation system. We are sorry to learn about your experience as you described in your original complaint. We would like to be of assistance and...

would like to talk to you further about this situation. Please contact Medtronic Neuromodulation Patient Services at [redacted] and ask for Patient Relations.
Initial Consumer Rebuttal /* (3000, 7, 2015/05/26) */
(The consumer indicated he/she DID NOT accept the response from the business.)
I have not received any remedy but an apology and information about a "Patient Advocate Foundation" so I receive assistance with co-payments. About the issues developed due to the defective stimulation programmer it seems it has vanished from the clinic at KP. I was advised by my pain management doctor Medtronics rep have control on these units. Today Medtronics told me otherwise and also was advised there is no warranty on the 7-day trial, meaning anything that happens to one person including death one is responsible because one signs a consent for treatment. Then why don't they tell people or post this information clearly so people better understand the risks. I signed this consent seconds before going into the operating room, and I was already half sedated. They had forgotten to have me signed this before. This is very unprofessional and it's senseless that in such risky procedures there is no factory warranty. I inquired about this and there is indeed patients rights that protect us, but it seems Medtronics is not willing to accept responsibility even as I was provided with a faulty unit, so they say I now have to live like this. This is totally unethical and unacceptable and should be reported to the FDA.
The model in question is the Medtronic MyStim model # 97740. Different codes were received and reported to the nurse in charge of the trial but until today no answers were received.
Final Consumer Response /* (3000, 12, 2015/06/08) */
(The consumer indicated he/she DID NOT accept the response from the business.)
Patient Relations consultant has not been able to assist and was instructed to go back to my treating physician. Today he called me and advised all he can do is treat the symptoms caused by the spinal cord stimulation failure, but that is it. Now I have to go back to Medtronic and ask again. It seems at this points no side is willing to take responsibility.
Final Business Response /* (4000, 15, 2015/06/18) */
We have answered the consumer's questions regarding the product, and have also reviewed the product's labeling and warranty with him. The information the consumer provided does not indicate a problem with the device. We are sorry to hear about the patient's experience, however, the concerns he raises are medical in nature and need to be addressed by his physician.
Thank you for taking the time to address your concerns.

Final Consumer Response /* (2000, 6, 2015/08/12) */
Ryan S. At Medtronic gave me a "courtesy discount of 20%" that got the amount due to within $5 of what I show I owed. I consider this case closed. Thank you

Initial Business Response /* (1000, 11, 2015/06/17) */
Medtronic Diabetes has fully investigated Ms. [redacted]'s complaint regarding her daughter, [redacted]'s account. According to our records, a phone call took place on April 16, 2015 regarding a statement Ms. [redacted] received in the amount of $625.50....

A Patient Financial Services (PFS) Representative informed Ms. [redacted] that she may disregard the statement as a return for the CGM system was processed the day before on April 15, 2015. There was no discussion regarding the MySentry return with PFS on April 16, 2015. On April 20, 2015 a refund was issued to Ms. [redacted]'s Visa credit card in the amount of $581.90 for the CGM system. On May 15, 2015, PFS received an email from a Customer Service Center (CSC) Representative requesting a credit to be issued for the return of the MySentry product. The credit was requested on May 18, 2015, and processed on May 22, 2015. On May 28, 2015, check #[redacted] in the amount of $827.90 was issued and mailed to Ms. [redacted]. The total refunded amount for the CGM and MySentry systems was $1,409.80. The additional $296.60 is Ms. [redacted]'s co-payment for the insulin pump, which has not been returned. Ms. [redacted] has now been refunded the entirety of her out of pocket costs for the returned devices, which include CGM/sensors and the MySentry product. [redacted], and her mother, [redacted], are valued customers, and Medtronic Diabetes regrets any inconvenience Ms. [redacted] may have experienced.

I am rejecting this response because: I have had no contact from Medtronic regarding this issue, there is NO PATIENT EDUCATION provided on the device in question PRIOR to INSERTION of this device!
I have received multiple stories on this item from the Customer Service reps VS the Cardiologists, no one knows what is the correct process or time limit that is safe post battery expiration. Also, I have been informed that there have been NO CLINICAL STUDIES to look a the long term effects of leaving this device inserted AFTER the battery is no longer running!!

Hello, This complaint has been routed to the incorrect Medtronic Representative. I work in the Diabetes division for Medtronic. I also searched our directory for Catherine [redacted], and I was unable to locate a person by the name as an employee for Medtronic. Please consider re-routing this...

complaint to our Corporate OHQ in Minneapolis, Minnesota. Thank you,Brenna [redacted]Legal Program AnalystMedtronic Diabetes[redacted] Northridge, CA 91325

Spoke with Jackie a manager in customer service and she said that the product has been shipped and received and this case is resolved in their system.

Initial Business Response /* (1000, 5, 2015/11/05) */
Thank you for bringing this matter to my attention, and I appreciate the time allowed to investigate the issue. A Medtronic employee inadvertently omitted applying the survey credits to Mr. [redacted]'s account. The representative has been coached...

in the proper procedure to prevent this inadvertent omission in the future. Subsequently, Medtronic has amended Mr. [redacted]'s account and applied the survey credits, which now brings Mr. [redacted]'s balance to zero. Mr. [redacted] is a valued customer, and Medtronic regrets any inconvenience Mr. [redacted] may have experienced. Sincerely, Brenna [redacted], Legal Program Analyst.
Initial Consumer Rebuttal /* (2000, 7, 2015/11/06) */
(The consumer indicated he/she ACCEPTED the response from the business.)
I do accept this response. I got a statement just today that shows that I do have a zero balance with Medtronic. I hate that I had to take this course of action to resolve this problem. I will say this problem was resolved before but only to receive another bill a few days later showing otherwise. I really hope it is truly resolved.

Initial Business Response /* (1000, 11, 2016/02/01) */
Medtronic Diabetes has fully investigated Ms. [redacted]'s complaint regarding her product order and training. Per our internal notes, Medtronic requested a number of documents from Ms. [redacted]'s physician in order to begin the pre-authorization...

process that is mandated by her insurance company. The process was time-consuming and took longer than we anticipated. Ms. [redacted]'s CGM system was delivered on December 18, 2015, her pump was delivered on December 21, 2015 and training took place on these devices by a Certified Diabetes Educator via telephone on December 24, 2015. Ms. [redacted] is a valued customer and Medtronic Diabetes regrets any inconvenience Ms. [redacted] may have experienced.
Initial Consumer Rebuttal /* (3000, 13, 2016/02/09) */
(The consumer indicated he/she DID NOT accept the response from the business.)
I find it curious that the medtronic response to my initial complaint is that my insurance was at fault, as if the timing of the issues about which I complained were the only issues, and as though there was no issue with their own rollout procedures - Indeed, I never received any communication from medtronic that they were having any kind of trouble with my doctor or with my insurance (which I think they should most certainly have done if they were having that trouble) until after I called the first time in November or even December, I believe, asking when I was to expect my new pump.
It was only at that point that a medtronic employee told me it would take weeks to "put it through" - as in, it had not been "put through" yet. Had the medtronic employer that examined my file looked a bit harder, they would have noticed that, at the time of their response, my problem had still not been resolved. It is presumably resolved now, I believe, as of last Friday, the 5th of February, although, given my past few months of experience, I think we should give the replacement product enough time to prove itself.
I am, as of February 5, finally in receipt of a new sensor - a replacement sensor for the one I rec'd in December, 2015. I do not "accept" Medtronic's explanation as it is missing a great deal of subsequent information and facts since my initial complaint on 12/21/15.
Upon receipt of my pump on 12/21/15, I was finally able to use my new sensor, but the charger was faulty and I had to wait while Medtronic overnighted me a new one. When I rec'd the new one, I was able to schedule training on 12/24/15 over skype. I had a great training session - she was wonderful, and she went above and beyond the call of duty, scheduling on a holiday, understanding my concern and my recent experiences. All went well with new sensor until...
1/9/16, in an airport hotel, less than 10 hours away from leaving the country (which was my concern from the very beginning, as medtronic knows), when I had to call the Medtronic helpline to find out why my sensor seemed to be malfunctioning - thought it might be something I wasn't used to yet. As it turns out, the helpline person assisted me in determining there was a sensig error, and he instructed me that I needed to send the new sensor back for a replacement. I was speechless.
I went on my trip anyway, but this whole transaction just kept getting more complicated, more upsetting, and more dangerous, as now I was heading to a country, from where I could not phone or email medtronics if something went wrong, and I traveled without a sensor for a 9 days. I was beside myself on the phone with the individual from Medtronics - but, he couldn't do anything other than tell me how unfortunate it was that I was so frustrated.
When I got home from this trip, I was physically fine, fortunately, but my new replacement sensor had not arrived. I couldn't imagine why not, until I got a note from Medtronics that my replacement sensor was on backorder and I would have to wait even longer - I don't recall if it even gave me an estimation of how long. In the meantime, while I continued to wait again, I did receive an item I had not ordered from medtronics, which I thought was some sort of joke (a rubberized cover/protective device (?) for my pump). No explanation inside the box. Thanks!
I did receive a call today from medtronics, which I returned but got voice mail. Someone phoned me (a male)and left me a voice mail, letting me know that the legal department was handling my complaint - he emphasized that fact several times, as if to ensure I had taken note of that fact. Was that supposed to make me feel better? He asked if I was satisfied and if there was anything Medtronic could do to help me be more satisfied. I left a voice mail back for him saying I was pleased to know the "legal team" was on it - as I was sure it should be.
I had no adverse health issues while away, just sub-par, to say the least, attention to my blood sugar levels since I was without my sensor for the last 4 months (with the exception of the short 2 weeks after my initial sensor arrived in December). I have come to count on this sensor to have almost constant attention to what is happening to my blood sugar, especially when traveling and having less control over my diet and timing of meals. My glucometer got used a lot instead. And, fortunately, I had no emergency lows while I was sleeping, for which I had no alarm system.
Medtronic seems to think (by their response to my initial complaint) that they have no responsibility in the disastrous customer service and product break-down I experienced. Therefore, I will simply repeat what my initial complaint said - I have been one of your happiest customers with your products and service for years.What has happened?!?
I don't know why this product overhaul went so poorly for me, but it did! It was a disaster, and it seemed like everything that could go wrong, did go wrong. It not only frustrated me beyond belief, but it scared me, having to "go it alone" because your service and your products fell down on the job. I'm disappointed I can't count on medtronics. I think you ought to examine your customer service and your product oversight and figure out where it went wrong. As I said before, an apology would be appreciated, but what I really want, and I'm not sure you can get it for me, is my confidence in your company back.
Final Business Response /* (4000, 15, 2016/02/18) */
Ted [redacted] from our Executive Offices / Customer Support Team has been in touch with Ms. [redacted] in regard to her concerns with Medtronic. We've done an extensive review of the facts on Ms. [redacted]'s account with both our 24-Hour HelpLine and Sales Departments. We've determined areas of opportunity in which we could have done things differently; resulting in a more positive outcome for her. We've been in contact with Ms. [redacted] recently and intend to follow up with her this week to discuss our findings related to her concerns. If there is anything else needed from Ms. [redacted], regarding these concerns or anything in the future, she has direct contact information for Ted [redacted] who is always available to assist.
Final Consumer Response /* (2000, 17, 2016/02/25) */
(The consumer indicated he/she ACCEPTED the response from the business.)
I am satisfied with Medtronic's response, having thoroughly discussed the matter with a very competent employee, Mr. Ted [redacted], who was assigned to my complaint. My concerns have been addressed, and my requested resolution has been handled more than fairly. I have been offered explanations/solutions to handle my recent concerns, and have been offered solutions for any future issues that may arise.
I thank Medtronic and Mr. [redacted] not only for their extended and thorough investigation, but also for Mr. [redacted]'s determined problem-solving and his willingness to see a reasonable solution through to its end.