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

Model Number 5076

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877); Impedance Problem (2950)

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

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crt-p) system had a stored episode with noise on the right atrial (ra) lead and right ventricular (rv) lead channels.This resulted in oversensing on the ra channel as well as pacing inhibition of greater than two seconds on the rv channel.It was noted that there was a lead safety switch (lss) for the ra lead for high out of range impedance values.Technical services (ts) analyzed presenting electrogram (egm) then discussed troubleshooting by reprogramming device with health care professional (hcp).This lead remains in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17488689
• MDR Text Key: 320687981
• Report Number: MW5121388
• 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