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

Model Number 377208

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Insufficient Information (4580)

Event Type  malfunction  

Event Description

This device was implanted on (b)(6) 2013 and remains implanted at this time.This is noted due to patient having atrial fibrillation with excessive rates, depressed ejection fraction, but patient declines biventricular implantable cardioverter defibrillator (icd}, but agrees to biventricular pacer.The physician was dr.(b)(6) at (b)(6) center at (b)(6) university in (b)(6).No additional information is available.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17529353
• MDR Text Key: 321411149
• Report Number: MW5136281
• 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: 08/13/2013

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: 377208
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1