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

Model Number UNKNOWN BOSTON SCIENTIFIC PAIN STIRN DEVICE

Device Problem Failure to Charge (1085)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reporting that the patient was having difficulty charging.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BOSTON SCIENTIFIC PAIN STIM DEVICE
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17529622
• MDR Text Key: 321172257
• Report Number: MW5136547
• Device Sequence Number: 1
• Product Code: LGW
• 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: 04/14/2022

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 BOSTON SCIENTIFIC PAIN STIRN DEVICE
• Patient Sequence Number: 1