BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1223763 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03507
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 21, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    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 FIELD EXPERIENCE OF UNABLE TO INTERROGATE THE DEVICE WAS VERIFIED IN THE LABORATORY. A REGISTER IN THE DEVICE HAD A PARITY ERROR. DUE TO THE PARITY ERROR, THE DEVICE WOULD RESET DURING THE INTERROGATION. THIS CAUSED THE INTERROGATION TO BE INCOMPLETE, WHICH LED TO THE FIELD EXPERIENCE OF UNABLE TO INTERROGATE THE DEVICE. THE PARITY ERROR WAS PROBABLY INDUCED DURING THE RADIATION THERAPY MENTIONED IN THE EVENT DESCRIPTION. THE DEVICE WAS TESTED ON THE AUTOMATED TEST SYSTEM, AND IT PASSED ALL TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. IT WAS NOTED THAT THE PATIENT HAD RADIATION THERAPY.

    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 Required Intervention