BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 2984501 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00566
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. THE REPORTED NO COMMUNICATION WAS CONFIRMED AND WAS DUE TO A DEPLETED BATTERY. A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE BELOW THE EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND ON OUR AUTOMATED TESTING EQUIPMENT AND NO HIGH CURRENT DRAIN SOURCES WERE FOUND. THE BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. THE CAUSE OF THE BATTERY DEPLETIION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88577 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1