BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 1223445 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03649
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    August 28, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. UPON RECEIPT, THE DEVICE WAS INTERROGATED AND INDICATED A SOFTWARE RESET HAD OCCURRED. THE REASON FOR THE RESET WAS DUE TO PARITY ERRORS. AFTER THE PARITY ERRORS WERE CLEARED, THE DEVICE INTERROGATED NORMALLY ON THE BENCH. THE CAUSE OF THE PARITY ERROR COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1