BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF-4 CONNECTOR

    MDR report key: 4153534 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16336
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 20, 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
    AZ, 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 WAS OBSERVED VIA REMOTE TRANSMISSION. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632119 FORTIFY ASSURA DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR