BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFORIA 7 VR-T DX

    MDR report key: 10082449 · Received May 21, 2020

    Report

    Report Number
    MW5094645
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    April 28, 2016
    Report Date
    May 19, 2020
    Manufacturer
    BIOTRONIK SE & CO.KG
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL 2 INAPPROPRIATE SHOCK. WHILE DRIVING TO PICK UP MY NIECE FROM SCHOOL, I RECEIVED THE FIRST SHOCK AT 40 JOULES FROM MY BIOTRONIK DEFIBRILLATOR. I GOT OUT OF THE CAR AND RECEIVED MULTIPLE SHOCKS APPROXIMATELY EVERY 10-15 MINUTES. THE TEACHERS AND STAFF CALLED 911. WHEN THE AMBULANCE ARRIVED, PARAMEDICS WATCHED IN HORROR AS I RECEIVED MORE SHOCKS TO MY CHEST. ON MY WAY TO THE HOSPITAL I RECEIVED MORE SHOCKS TO MY CHEST. WHEN I ARRIVED AT THE HOSPITAL, THE STAFF RUSHED ME INTO A ROOM WHERE THEY GAVE ME AN IV AND MEDICATIONS TO RELAX MY HEART MUSCLE. I EXPERIENCED A TOTAL OF 15 SHOCKS ON THAT DAY. I WAS HOSPITALIZED FOR 4 DAYS. THIS WAS THE THIRD TIME MY BIOTRONIK DEFIBRILLATOR MISFIRED. THE FIRST TIME WAS IN (B)(6) 2016. THE SECOND TIME WAS (B)(6) 2016, WHICH THAT EVENING I EXPERIENCED 4 SHOCKS WHILE CONSCIOUS. THE TOTAL NUMBER OF INAPPROPRIATE SHOCKS THAT THE BIOTRONIK REPRESENTATIVE COULD NOT EXPLAIN EACH TIME, WERE 21 TORTUROUS SHOCKS WHILE I WAS CONSCIOUS. I HAD THE DEFIBRILLATOR TURNED OFF AFTER THE LAST INCIDENT ON APRIL (B)(6) 2016. RIGHT LEAD VENT - LINOX SMART S DX 65/15 REF 365500, SN (B)(4) IFORIA 7 VR - T DX BIOTRONIK REF 390090, SN (B)(4) PID 56. RECEIVED MULTIPLE SHOCKS FROM BIOTRONIK RIGHT VENT LEAD ON (B)(6) 2016, WHILE DRIVING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541803 IFORIA 7 VR-T DX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BIOTRONIK SE & CO.KG 390090
    541804 LINOX SMART S DX 65/15 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BIOTRONIK SE & CO.KG 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| O| R| S