BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA VR, DF4 CONNECTOR

    MDR report key: 3101123 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01914
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 6, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 OVERSENSING WAS OBSERVED WHEN THE PATIENT RECEIVED NON-SUSTAINED LEAD NOISE ALERT. THE DEVICE WAS REPROGRAMMED BASED ON THE SUGGESTIONS FROM TECHNICAL SERVICES. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203420 FORTIFY ASSURA VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR