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

Model Number 5076

Device Problems Under-Sensing (1661); Impedance Problem (2950)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Event Description

It was reported that the system with a cardiac resynchronization therapy pacemaker (crt-p) and this non boston scientific right atrial (ra) lead has been showing unstable pacing impedance values to high, out of range values.The patient appears to be in chronic atrial fibrillation, so no observation of noise.Under sensing has been observed on stored events.Various options were discussed as the cause for the observed behavior.The device was recommended to be reprogrammed.The crt-p and this ra lead remain 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: 17488670
• MDR Text Key: 320683258
• Report Number: MW5121369
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5076
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1