BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II HF CRT-D

    MDR report key: 2984347 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00611
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    October 2, 2012
    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 Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE DEVICE WAS RETURNED DUE TO PREMATURE BATTERY DEPLETION. A LONGEVITY CALCULATION WAS PERFORMED BASED ON PROGRAMMED SETTINGS AND USAGE DATA AND THE DEVICE WAS FOUND TO BE WITHIN EXPECTED LONGEVITY PERFORMANCE. WITH A REPLACEMENT BATTERY ATTACHED, THE DEVICE TESTED NORMALLY AND NO SOURCES OF HIGH CURRENT DRAIN WERE DETECTED. THE CAUSE OF BATTERY DEPLETION WAS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE ERI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87805 ATLAS II HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR