BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA ST DR

    MDR report key: 3903636 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12726
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED INAPPROPRIATE AUTO MODE SWITCH EPISODE DUE TO FAR-FIELD ATRIAL OVERSENSING. PROGRAMMING CHANGES WERE MADE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381109 FORTIFY ASSURA ST DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2359-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1