BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3911048 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12944
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED OVERSENSING ON THE VENTRICULAR CHANNEL RESULTING IN INAPPROPRIATE ATP THERAPY. INTERMITTENT OVERSENSING INTERVALS WERE NOTED. FURTHER INVESTIGATION WAS RECOMMENDED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385924 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR