BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 2242397 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06643
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    July 22, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED NO COMMUNICATION WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO LOW BATTERY VOLTAGE. THE DEVICE WAS TESTED ON THE BENCH AND ON OUR AUTOMATED TESTING EQUIPMENT AND NO SOURCES OF HIGH CURRENT DRAIN WERE FOUND. THE BATTERY WAS RETURNED TO THE MANUFACTURER FOR ADDITIONAL ANALYSIS. NO ANOMALIES WERE FOUND THAT WOULD LEAD TO PREMATURE BATTERY DEPLETION. THE CAUSE OF THE LOW BATTERY VOLTAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN-CLINIC WITH DIZZINESS AND NO PACING SUPPORT. DEVICE COULD NOT BE INTERROGATED. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention