MAUDE Adverse Event Report: MEDTRONIC INC. STIMULATOR, NEUROMUSCULAR, LOWER BACK MUSCLES, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 5054

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that this non-boston scientific right atrial (ra) lead pacing impedance was out of range.The ra lead was not in use due to the device appears to have been programmed to vvi (ventricular inhibited) since 2020.There are no allegations against this device nor evidence of malfunction.No adverse patient effects were reported.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, NEUROMUSCULAR, LOWER BACK MUSCLES, TOTALLY IMPLANTED FOR PAIN RELIEF
• Type of Device: STIMULATOR, NEUROMUSCULAR, LOWER BACK MUSCLES, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 18267328
• MDR Text Key: 329824488
• Report Number: MW5148777
• Device Sequence Number: 1
• Product Code: QLK
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5054
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1