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

Patient Problem Insufficient Information (4580)

Event Type  Other  

Event Description

Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient said she is having issues with the generator.It is telling her she needs to replace the generator and generator is not working (b)(6).Patient said her representative was (b)(6) and dr.(b)(6) was the doctor that installed the system.Pt did not have mdt equipment and was redirected to abbott.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE NEUROSTIMULATION SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18949580
• MDR Text Key: 338373800
• Report Number: MW5153036
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1