BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3953207 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13552
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 4, 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
    OH, US
    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 PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE DEVICE WAS POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE DURING DEVICE CHECK. THE PATIENT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431209 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR