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

Model Number M51PSEMIBLUE

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The patient reported their leads were in the wrong place.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN LEADS
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534770
• MDR Text Key: 321433235
• Report Number: MW5141670
• 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: 03/07/2016

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: M51PSEMIBLUE
• Device Catalogue Number: M51P/SEMI/DG/W18/VAH/FF/BL90FB
• Patient Sequence Number: 1