BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF4 CONNECTOR

    MDR report key: 3101098 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01909
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 27, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 THE REPORTED OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. AN ARC MARK WAS OBSERVED ON THE ICD CAN. FURTHER EVALUATION OF THE ARC MARK INDICATED THE PRESENCE OF LEAD MATERIAL. THE DAMAGE FOUND IS CONSISTENT WITH THAT CAUSED BY ARCING BETWEEN THE HV CONDUCTOR AND THE ICD CAN. THE LOW VOLTAGE FUNCTIONALITY WAS TESTED ON THE BENCH AND WAS FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO OUTPUT CURCUIT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204501 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 Required Intervention (B)(4)