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

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Caller reported the patient had a boston scientific spinal cord system implanted and removed/revised in 2018.Removal was because of "failure of stimulator" per the op notes.Managing physician was noted to be "dr (b)(6)" (correct spelling unknown).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BOSTON SCIENTIFIC SPINAL CORD SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17533376
• MDR Text Key: 321165767
• Report Number: MW5140280
• 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: 04/11/2022

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