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

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).

• Brand Name: PRECISION MONTAGE MRI
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11125224
• MDR Text Key: 225521686
• Report Number: MW5098681
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC-1200
• 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: 23 YR
• Patient Weight: 129