BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVA QUAD XT

    MDR report key: 6058225 · Received October 26, 2016

    Report

    Report Number
    3004209178-2016-22588
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALERTS WERE RECEIVED INDICATING VENTRICULAR DEFIBRILLATION IMPEDANCE WAS OUT OF RANGE AND SHOCKS WERE DELIVERED. THE CLINIC WAS NOTIFIED OF THE ALERTS. POLICE WERE CALLED AND FOUND THE PATIENT DECEASED AT HOME. REVIEW OF STORED DATA REVEALED THE DEVICE DELIVERED MULTIPLE SHOCKS AT THE TIME OF DEATH BUT THE VENTRICULAR ARRHYTHMIA WAS NOT TERMINATED. THE PATIENT PRESUMABLY DIED AT OR ABOUT THE TIME OF THE DELIVERED SHOCK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708826 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death 6935M62 LEAD, 459888 LEAD, 5076-52 LEAD