BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 1831029 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03656
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    June 14, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT RECENTLY HAD A HEARTMATE II LVAD IMPLANTED, AND THE ICD COULD NOT SUCCESSFULLY BE INTERROGATED. THE PHYSICIAN HAS DECIDED TO KEEP DISABLED THE HV THERAPY AND NOT CHANGE THE LVAD SETTINGS TO ALLOW FURTHER ATTEMPT AT INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR