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

Device Problem Human-Device Interface Problem (2949)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the healthcare professional experienced issues using the fixate device during an implant procedure.(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, TOTALLY IMPLANTED FOR PAIN RELIEF
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17528758
• MDR Text Key: 321064936
• Report Number: MW5135687
• 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: 04/03/2015

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
• Patient Sequence Number: 1