BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR ICD_O_US

    MDR report key: 6079432 · Received November 4, 2016

    Report

    Report Number
    2938836-2016-13802
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    September 23, 2016
    Report Date
    June 29, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    Z-0115-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS OBSERVED ON THE DEVICE. DEVICE EXPLANT PROCEDURE WAS RECOMMENDED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731256 FORTIFY ASSURA VR ICD_O_US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1259-40Q 3882741

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R