BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3910980 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-13016
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 27, 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 Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VIA MERLIN.NET TRANSMISSION, POST PACED T WAVE OVERSENSING WAS OBSERVED. REPROGRAMMING WAS RECOMMENDED. PATIENT WAS ASYMPTOMATIC. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386493 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2359-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR