MAUDE Adverse Event Report: BOSTON SCIENTIFIC STIMULATOR, SPINAL- CORD, IMPLANTED ( PAIN RELIEF); STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number UNKNOWN PERCUTANEOUS LEADS

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the percutaneous leads had migrated, and a laminectomy procedure was performed to anchor the leads down.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, SPINAL- CORD, IMPLANTED ( PAIN RELIEF)
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17535851
• MDR Text Key: 321045963
• Report Number: MW5142744
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN PERCUTANEOUS LEADS
• Patient Sequence Number: 1