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

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The reason for call was pt said their boston scientific ins was not working for them at all and mentioned that they had met with the reps to get it reprogrammed which did not resolve their issue.Pt's reason for call was to see if the mdt ins would work for their chronic back pain.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BOSTON SCIENTIFIC INS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17532089
• MDR Text Key: 321268505
• Report Number: MW5138998
• 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: 01/21/2022

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
• Patient Sequence Number: 1