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

Model Number 3830

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this implantable lead was placed in the bundle of his and in the right atrial (ra) port on the pacemaker.The patient needed a cardiac resynchronization therapy pacemaker (crt-p) upgrade and the lead was connected to the left ventricular (lv) port on the new crt-p.At this time, no adverse patient effects have been reported.This product remains in-service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17489842
• MDR Text Key: 320695019
• Report Number: MW5122360
• 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: 03/31/2023

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: 3830
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1