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

Model Number 3660

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 12/31/2023

Event Type  Injury  

Event Description

Patient called to report that her abbott spinal stimulator stopped working on new years eve.Patient stated the controller has an error message that reads "replace generator- has reached end of service".Patient stated the device is no longer working and she is left with no pain control.Patient planned to contact physician for guidance.

• Brand Name: SPINAL STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18475165
• MDR Text Key: 332638791
• Report Number: MW5149948
• 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: Patient
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3660
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female