BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1895851 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04782
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED, THE DEVICE EXHIBITED NO COMMUNICATION DUE TO NORMAL BATTERY DEPLETION. WITH A NEW BATTERY, THE DEVICE TESTED NORMAL, AND NO HIGH CURRENT DRAIN SOURCES WERE FOUND. AUTOMATED ELECTRICAL TESTING FOUND NO ANOMALIES AND THE DEVICE MET ALL SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION THE DEVICE WAS FOUND IN HARDWARE BACKUP (HWVVI). THE DEVICE COULD NOT BE RESTORED. THE DEVICE WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-340 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention