BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 2242400 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06652
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    July 6, 2011
    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
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS DID NOT CONFIRM THE PREMATURE BATTERY DEPLETION. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED IN THE AUTOMATED SYSTEM; NO ANOMALIES WERE FOUND AND THE DEVICE MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT FOLLOW-UP, DEVICE WAS FOUND TO BE BELOW EOL. NO THERAPY HAS BEEN DELIVERED SINCE LAST FOLLOW-UP. PATIENT NOTIFIER WAS NOT RECEIVED. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-366 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention