BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS HF

    MDR report key: 2890108 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10802
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 30, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED RAPID BATTERY DEPLETION FROM ERI TO EOS WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED MANUALLY ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO HIGH CURRENT DRAIN SOURCES WERE OBSERVED. WHILE THE DEVICE WAS WITHIN THE LIMITS FOR OVERALL LONGEVITY REQUIREMENTS, THE SUDDEN DROP IN BATTERY VOLTAGE IS ABNORMAL. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO BATTERY ANOMALIES THAT COULD LEAD TO INTERNAL LOADING WERE DETECTED. THE CAUSE OF THE RAPID BATTERY DEPLETION COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WAS EXPLANTED AND REPLACED DUE TO RAPID DEPLETION FROM ERI TO EOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-367 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR