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

Model Number 355263

Device Problem Low impedance (2285)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This device was implanted on (b)(6) 2009 and was explanted on (b)(6) 2013 for an unknown reason with shock impedance of 150 ohms.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6).No other information is available.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: 17534971
• MDR Text Key: 321173953
• Report Number: MW5141871
• 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: 12/17/2013

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: 355263
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1