BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 6949991 · Received October 13, 2017

    Report

    Report Number
    2938836-2017-32881
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 21, 2017
    Report Date
    June 5, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z-0115-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    DATE RETURNED TO MANUFACTURER UPDATED FROM 08/02/2017 TO 10/02/2017.

    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. THE PATIENT WAS GOOD POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727593 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC. CD2357-40C 4346310

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R