BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRONIK PACEMAKER/DEFIBRILLATOR

    MDR report key: 14829702 · Received June 24, 2022

    Report

    Report Number
    MW5110512
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    March 28, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    MRM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BIOTRONICK DEFIBRILLATOR MALFUNCTIONED CAUSING THE IMPLANTED UNIT TO SHOCK THE PATIENT TWICE. THE LEAD CONNECTION WIRE HAD FRACTURED, THIS IS IMPLANTED IN THE HEART, THE UNIT IDENTIFIED THAT THE PATIENT HEART HAD STOPPED CAUSING THE TWO SHOCKS FIRST ONE FOLLOWED BY SECOND 18 MINUTES LATER. HOSPITAL RECORDS STATE THIS WAS A MALFUNCTION BY THE DEVICE, I CONTACTED BIOTRONIK BELOW AFTER IT HAPPENED TO THIS PERSON WHO REFUSED TO RESPOND FOR MONTHS. (B)(6) BEST REGARDS, (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735927 BIOTRONIK PACEMAKER/DEFIBRILLATOR DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM BIOTRONIK, INC. ILESTRO 7 DR-T DF-1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Disability| L| O| R| H WILL DISCLOSE LATER