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

Model Number	SC-5552-1
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Event or Problem Description
The device is always hot to the touch on the skin.It moves and causes severe pain and swelling in my legs.I can barely walk sometimes.The device stopped working.Fda safety report id # (b)(4).

• Brand Name: NERVE STIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12245450
• Report Number: MW5102838
• Device Sequence Number: 2871156
• Product Code: LGW
• UDI-Device Identifier: 08714729907077
• UDI-Public: 0108714729907077
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: No Information
• Device Model Number: SC-5552-1
• Device Catalogue Number: 2017-12-09
• Device Lot Number: 552641
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Weight: 112