MAUDE Adverse Event Report: BIOTRONIK DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number 346543

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The lead was explanted on (b)(6) 2011.Lead not functioning, impedance > 2000, no sensing and no capture.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17529825
• MDR Text Key: 321147008
• Report Number: MW5136748
• Device Sequence Number: 1
• Product Code: MRM
• 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: 05/04/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 346543
• Patient Sequence Number: 1