BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 3220171 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04539
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 7, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW UP, PATIENT HAD A SYNCOPAL EPISODE WHILE RIDING HIS BIKE AND FRACTURED HIS LEG. NO VT/VF EPISODES WERE LOGGED IN THE DEVICE AND NO NOISE WAS PRESENT ON THE REAL TIME EGM. PATIENT IS IN STABLE CONDITION AND HAS BEEN RELEASED FROM THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320220 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR