BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3791053 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10380
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 16, 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
    IA, US
    Reporter Occupation
    NURSE

    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 NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL WAS NOTED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. RECOMMENDED PROGRAMMING CHANGES WERE MADE, AND NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268651 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR