BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF4 CONNECTOR

    MDR report key: 3791008 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10369
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 26, 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
    AK, 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 REMOTE TRANSMISSION WAS RECEIVED FOR NON-SUSTAINED LEAD NOISE. REVIEW OF THE EPISODES REVEALED FUNCTIONAL LOSS OF VENTRICULAR CAPTURE DUE TO ATRIAL BLANKING OF PREMATURE ATRIAL CONTRACTIONS, LEADING TO THE INCORRECT EPISODES. THE DEVICE WAS REPROGRAMMED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268196 FORTIFY ASSURA DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR