BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS HF CRT-D

    MDR report key: 1073596 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02480
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    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

    THE ANALYSIS CONFIRMED THE PREMATURE BATTERY DEPLETION. LONGEVITY CALCULATION INDICATES THAT THE BATTERY VOLTAGE IS LOWER THAN EXPECTED GIVEN THE PROGRAMMED PARAMETERS THAT WERE AVAILABLE. WITH ANOTHER BATTERY ATTACHED, THE POWER CONSUMPTION OF THE DEVICE WAS MEASURED AND FOUND TO BE NORMAL.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECEASED. IT WAS NOTED THAT THE LEAD EXHIBITED A MECHANICAL PROBLEM. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION AFTER 6 MONTHS OF IMPLANT.

    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 73 YR Required Intervention