MAUDE Adverse Event Report: ST JUDE MEDICAL ABBOTT PERCUTANEOUS LEAD BATTERY; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that physician and patient chose to replace abbot battery, which is at its end of service with medtronic battery.Patient has two percutaneous abbot leads in place.Physician declined replacing non medtronic leads with medtronic leads.Upon connecting adaptor to leads, impedance issues appeared to 2 electrodes.Physician aware and acknowledged that they electrode may not be able to be used.No issues programming around these electrodes.Medtronic reference number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ABBOTT PERCUTANEOUS LEAD BATTERY
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ST JUDE MEDICAL
• MDR Report Key: 17488540
• MDR Text Key: 320709902
• Report Number: MW5121239
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1