MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)

Event Date 11/01/2017

Event Type  Injury  

Event Description

Defective device; i am reporting that the stimulator either continues to create unwanted stimulation or my body has emulated the device's stimulation with the device turned off and even with the battery completely discharged.The unwanted stimulation is worst now after hip pain started, after their additional programs were installed & one new program creates terrible pain when running on its own.My body has received 2 electrical shocks this year that made my whole body jump and then the stimulation stopped for a short time along with the pain the stimulator creates.I called fda (b)(4) complaint number, (b)(4), on (b)(6) 2020 and again (b)(6) 2020 to report the faulty simulator.My first call also asked if i should call fda to report the problem or if i should submit a medwatch form.No reply, so how should i report what has become a severe, dangerous and unfixable problem with boston scientific's spinal chord stimulator.I am looking for help to resolve their problem and to warn others before installing their device.I know the fda is busy but that does not excuse the poor customer service by not returning my calls.I knew they were busy but i doubt they are that busy (18-19 days).I made the first fda call shortly after talking with boston scientific again (b)(6) 2020.I thought this time they would find a solution but they only called me for a status update.I was surprised, discouraged and upset as i was told earlier they were working on a solution to the problem, and i was not supposed to be doing anything after (b)(6) 2019 doctor's appointment.Both calls stated that the problem started in 2017, i contacted boston scientific (b)(6) 2017 via (b)(6) and they arranged via phone calls to download the stimulator data on (b)(6) 2018 during one doctor appointment.I was to hear back the results/report from them in 4-6 weeks but that never happened.After a year of additional pain, anguish and disappointment - boston scientific told me again they never heard of this problem.I had sent them three urls from a spinal chord forum site showing the same or similar problems.Arrangements were made to go back to my 2014 doctor on (b)(6) 2019.No one from boston scientific came to the appointment.Another appointment was made on (b)(6) 2019 for a boston scientific expert and they came to this appointment after missing the first 2019 appointment.The expert created another program that i thought was to diagnose any problems but apparently not.Another appointment was made on (b)(6) 2019 to obtain results from appointment with their expert.Instead of diagnosing anything another technician created three more programs and another appointment was made for three weeks.My left hip also started being painful after the expert tried to create his program and the program was installed.No one from boston scientific showed up to the (b)(6) 2019 (4th) appointment so the doctor discussed pain options.I wanted to discuss one of the three new programs, as it could not be turned off, intensity regulated and it created severe pain.It also would turn off and back on by itself without any determined schedule.I considered it the program from hell that i am still experiencing.All but one option was to repeat several pain treatments that did not work in 2012-2014.The only option about the stimulator was once again to have it removed.I had stated from the beginning in 2018 and repeatedly afterwards that i wanted no more surgeries unless it was positively known to fix the problem.The doctor supplied me with their neurosurgeon's phone number if i wanted to talk with him.I stated again i would not have it removed unless it was known to fix the problem.Calls in 2020 continued when i sent e-mail messages to the ceo that apparently told the support department to do something.They changed the wording from the (b)(6) 2019 appointment they did not attend to be, 'the surgeon would tell me if removing the device would stop the problem'.Ran out of characters.Fda safety report id # (b)(4).

Event Description

Add'l info received from reporter on 05/06/2020 for report # mw5093987.I had the bs scs installed in 2014.It never helped much.Around (b)(6) 2017 i started noticing the scs was stimulating when the device was off.I reported it to bs (b)(6) 2017.Help, i submitted another medwatch report and never received a response so i do not have a number for it.I also called (b)(6) complaint line twice in (b)(6) and am still waiting on replies.The stimulator is still inside my body.Boston scientific (bs) has all data downloaded from the faulty device.I am worse off now since bs had me follow their instructions to supposedly find the problem.Bs has never helped and i believe they never intended to help.Bottom line is the stimulator will not shut off and causes me pain, electrical shocks and stop me from sleeping as it wakes me and cause me to have trouble getting to sleep.Fda safety report id # (b)(4).

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 9910027
• MDR Text Key: 186136653
• Report Number: MW5093987
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 75 DA
• Patient Weight: 141