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

Model Number 6516

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6), 2009 and remains implanted at this time.This is noted due to rumors noticed on the rv electrocardiogram.Performing the test, normal parameters were noticed with measurements sensing of 25mv, impedance of1086 ohms and threshold 1,4vxo, 5ms.During pocket manipulation or patient movements the impedance was the same with some measurements of 200- 300ohms.In the daily measurements, we noticed a normal trend with only one measurement at the end of (b)(6) of 200 ohms.In the memory we have found 5 episodes of fv with anti-tachycardia pacing {atp) due to rumors and an fv with anti-tachycardia pacing (atp) and shock always due to rumors.All the episodes started on (b)(6), 2014.They suspected a lead fracture and a new lead will be implanted.The physician was dr.(b)(6) at (b)(6), italy.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: 17525744
• MDR Text Key: 321444714
• Report Number: MW5132685
• 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: 03/31/2014

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: 6516
• Patient Sequence Number: 1