MAUDE Adverse Event Report: ABBOTT MEDICAL SCS SYSTEM; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

The reason for call was caller reported that they have high impedance on one of the 'contacts' and three of them have low impedance.Caller said their scs was not working properly and they were about to have it removed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SCS SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18133005
• MDR Text Key: 328226471
• Report Number: MW5148109
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1