BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS HF CRT-D

    MDR report key: 1830976 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03675
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 4, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 DEVICE SHOWED A PREMATURE BATTERY DEPLETION. THE DEVICE DID NOT DELIVER ATP OR SHOCKS BUT WAS PROGRAMMED TO HIGH OUTPUT SETTINGS. THE DEVICE WAS REMOVED AND REPLACED.

    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-343 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention