BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR ICD_IDE_US

    MDR report key: 6992269 · Received October 31, 2017

    Report

    Report Number
    2938836-2017-33424
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    October 13, 2017
    Report Date
    October 15, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P910023
    Removal / Correction Number
    Z-0115-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PREMATURE BATTERY DEPLETION WAS CONFIRMED BY ANALYSIS. BENCH TESTING ON THE DEVICE WAS PERFORMED, AND NO SOURCES OF HIGH CURRENT WERE NOTED. IN FURTHER ANALYSIS OF THE BATTERY, LITHIUM CLUSTERS WERE OBSERVED, BUT AT THE TIME OF ANALYSIS THE CLUSTERS DID NOT APPEAR TO BE IN A LOCATION OR SIZE THAT WOULD BE SUFFICIENT TO CAUSE AN INTERNAL SHORT OF THE BATTERY. AS A RESULT, THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, FROM THESE ANALYSES, IN THE ABSENCE OF OTHER ROOT CAUSES, IT IS PROBABLE THAT THE PREMATURE BATTERY DEPLETION WAS CAUSED BY A LITHIUM CLUSTER INDUCED SHORT CIRCUIT. THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY NOTICE ISSUED BY ST. JUDE MEDICAL ON 11 OCTOBER 2016.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PMA/510(K) # SHOULD HAVE BEEN P910023.

    Description of Event or Problem · 1

    FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. PATIENT WAS STABLE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770808 FORTIFY ASSURA VR ICD_IDE_US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC. CD1257-40Q 4070461

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R