BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 1831087 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03628
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE IMPEDANCE ANOMALY WAS VERIFIED VIA THE MONTHLY TREND MEASUREMENTS. TESTING ON THE BENCH AND ON THE AUTOMATED TEST EQUIPMENT FOUND NO ANOMALIES. THE DEVICE MET ALL SPECIFICATIONS. THE CAUSE OF THE LEAD IMPEDANCE ANOMALY WAS NOT DETERMINED; HOWEVER, IT IS SUSPECTED TO BE LEAD RELATED. THE THRESHOLD ANOMALY WAS NOT REPRODUCED IN THE LABORATORY BUT IS ALSO BELIEVED TO BE LEAD RELATED.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS REPLACED DUE TO HIGH IMPEDANCE AND HIGH THRESHOLDS. THE MEASUREMENTS INCREASED AFTER THE PATIENT FELL FROM A ROOF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 1581/65, (B)(4)