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U.S. Department of Health and Human Services


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Device Problems Migration or Expulsion of Device (1395); Battery Problem (2885); Material Protrusion/Extrusion (2979)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description

I have two stimwave stimq devices implanted in my right shoulder/back/neck. They terminate at the greater occipital nerve on either side of my neck. Devices were implanted after 25+ years of chronic migraine pain. The clinical trial went very well - the externally-located unit and battery provided approx 75% relief, so we had the devices permanently implanted. The clinical trial was in (b)(6) 2018; the permanent implantation surgeries were in q1 2019. Since the implantation surgeries, i have had a myriad of problems: one of the implants migrated and had to be removed in emergency surgery. The healing process resulted in multiple repeat visits for sutures and implant parts extruding from my back. The skin healing process (or lack thereof) has left numerous disfiguring scars which are paper-thin. I am still having debris (internal sutures) extruding from the scar tissue at this time. The pain relief i received during the trial has never been matched. At best, relief levels are approx 30%. The batteries that power the external wearable antenna assembly (waa) have failed at an alarming rate. I am currently in possession of batteries #5 and #6; the first four failed completely and have to be rma'd with stimwave. For a timeframe of approx 18 months, the number of device failures is exceedingly high. As for the impact on my life due to the repeated problems with these devices: i have been on short term disability, long-term disability, and ultimately lost one job (so far) due to an inability to work. I have been at my current role for less than one year. I exhausted all of the pto i was given in my initial offer letter/signing package for fy 2019, and i have already exhausted my pto allocation for fy 2020 because of the number of days i have had to miss work due to the incapacitating pain. I have lost most independence in my life, i can only drive at specific times (depending on how i am feeling). I cannot care for my pregnant wife; and i cannot care for my (b)(6) year-old son. Most recently, after batteries #3 and #4 failed within days of each other, i had to follow stimwave's rma process to receive new batteries. This left me without any batteries to power my implants for 23 days. Given that it is prohibited by my care team to treat my pain with narcotics (painkillers), and that i do not have any prescribed medication that i can take for pain relief that is non-narcotic, trying to simply survive for more than three weeks with no relief was a test of endurance. I understand that rma processes take time; however, i do not feel that it is acceptable in any scenario to have patients; patients who rely upon these devices operating properly, and, in my case, have multiple internal implanted devices that require the battery power to operate whatsoever - try to cope with and struggle through the nightmare of not having devices that are relied upon. I have contacted stimwave, and have an invitation at this time from the stimwave cto to meet with their complaint specialist. However, i am somewhat reluctant to do so, as i feel that i am being invited to this meeting to both discuss my grievances and to be thoroughly interrogated. I am uncomfortable with the idea of having a 'negative patient report' with stimwave - whose products are implanted in my body, due to the concerns i have with the efficacy, quality, and reliability of the products. I have also received email communications from stimwave which intimated/articulated that they are aware of the quality issues related to their battery units. It is also alluded to that this was the cause behind replacements of stimwave executives earlier this year. I am certainly happy to share any information i have received. Fda safety report id# (b)(4).

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Manufacturer (Section D)
MDR Report Key10250007
MDR Text Key198310683
Report NumberMW5095426
Device Sequence Number1
Product Code GZF
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/06/2020
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
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
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Date Received: 07/08/2020 Patient Sequence Number: 1