BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR, DF4 CONNECTOR

    MDR report key: 3210560 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03356
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DURING A REGULAR FOLLOW UP, HIGH VOLTAGE LEAD IMPEDANCE OUT OF RANGE ALERT WAS OBSERVED. HIGH VOLTAGE LEAD IMPEDANCE WAS TESTED IN-CLINIC AND THE RESULTS WERE NORMAL. THE DEVICE REMAINS IMPLANTED AND THE PATIENT WILL BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT ALERTS FOR HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WERE OBSERVED. MEASUREMENTS WERE PERFORMED AND FOUND WITHIN NORMAL RANGE. THE PATIENT ALERT FOR OUT OF RANGE HV LEAD IMPEDANCE WAS PROGRAMMED OFF. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310725 FORTIFY VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1