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

Model Number	SC-1200
Medical Device Problem Codes	Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Response, Decreased (2271); Disability (2371)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
After receiving spinal cord stimulator developed new and increased pain in back muscles and spine.Stimulator overheated and caused shocks even after turning product off with remote.Had revision surgery (b)(6) 2019 at which time pain became debilitating.On (b)(6) 2020 had stimulator removed.Have had to file for disability.Severe pain.Fda safety report id # (b)(4).

• Brand Name: PRECISION MONTAGE MRI SPINAL CORD STIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10483001
• Report Number: MW5096383
• Device Sequence Number: 15317256
• Product Code: LGW
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SC-1200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 52 YR
• Patient Weight: 68