MAUDE Adverse Event Report: MEDTRONIC LV LEAD; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number 5076

Device Problems Ambient Noise Problem (2877); High Capture Threshold (3266)

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

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crtp) recorded high thresholds in right ventricular (rv).There were episodes of far-field r-wave oversensing noise with the right atrial (ra) lead.Significantly over the last year, the left ventricular (lv) lead experienced an increase in pacing impedance measurement but remains within normal limits.Technical services recommended troubleshooting options.No adverse patient effects were reported.The device and competitor rv, competitor ra and unknown lv lead remains ln-service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LV LEAD
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17488746
• MDR Text Key: 320706415
• Report Number: MW5121445
• Device Sequence Number: 1
• Product Code: NKE
• 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: 11/25/2022

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
• Device Model Number: 5076
• Patient Sequence Number: 1