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

Model Number ILESTO 7 VR-T

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Type  malfunction  

Event Description

This device was implanted on (b)(6) 2014 and was explanted on (b)(6) 2016 due to gross lead fracture with multiple resultant, in appropriate shocks.The physician was dr.(b)(6) at (b)(6) medical center 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: 17529239
• MDR Text Key: 321423226
• Report Number: MW5136169
• 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: 01/13/2017

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: ILESTO 7 VR-T
• Patient Sequence Number: 1