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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC CORPORATION PRECISION MONTAGE MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-1200
Device Problem Unintended Movement (3026)
Patient Problems Burn(s) (1757); Pain (1994); Reaction (2414); Ambulation Difficulties (2544); Electric Shock (2554)
Event Date 12/24/2020
Event Type  Injury  
Event Description

Adrenal crisis; i initially had the device implanted in (b)(6) 2020, which burned and shocked me and rejected, and i reported my symptoms in (b)(6) 2020, and the physician did not revise the implant until the end of (b)(6). On (b)(6) 2020, i slipped and fell down icy stairs. I struck my lower back, slightly lower than where the ipg is implanted on the right side. Over the course of the next few days, i noticed that the ipg was turned/flipped out horizontally so that it was "sticking outward" in my back. The ipg is also so close to the skin that the port where the leads connect to the ipg can clearly be felt as well as the rest of the outline of the device. I have severe pain at the ipg site, into my hip and up into my ribs. I cannot walk and i'm in severe pain despite my current pain regimen. After the implant was replaced by the pain center i was seeing in (b)(6), i switched to a different pain center because i felt that my medical issues and the first incident with the ipg implant burning, shocking and rejecting me was neglected and that i was mistreated. I have reached out to the hospital, as i have not moved, to ask them to see me in the office to look at the stimulator site/ipg and the horrific positioning. I sent them pictures as well. They refused to see me at all and i asked the nurse if she saw the pictures and told her the stimulator was sticking outward in my back and she stated rudely "is it sticking out of your skin?". I contacted my current pain center and they are not able to help me with the issue regarding the device because they did not implant it. In addition, i have a secondary medical condition, adrenal insufficiency, where my body does not produce steroids and when under stress, even though i supplement daily with steroids, i can quickly become ill and go unconscious, unless i inject myself with a large amount of steroids. Due to the pain from the ipg and the pain into my hip and ribs, i have had to use this injection 4 times in the past week since the ipg has begun turning and it's been worsening. I have contacted my representative for the device and the corporate office who all agree it's an emergency to have this looked at, but the hospital that implanted it is refusing to see me and i am in excruciating pain with the risk of going unconscious nearly every day from the pain and stress induced from this being left untreated and unaddressed. Fda safety report id# (b)(4).

 
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Brand NamePRECISION MONTAGE MRI
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key11125224
MDR Text Key225521686
Report NumberMW5098681
Device Sequence Number1
Product Code LGW
Combination Product (Y/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 01/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberSC-1200
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

Patient TREATMENT DATA
Date Received: 01/05/2021 Patient Sequence Number: 1
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