BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 3090171 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01278
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 27, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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

    IT WAS REPORTED THAT DURING INTERROGATION THE DEVICE WAS OPERATING IN HARDWARE BACKUP VVI MODE WITH NO THERAPIES AVAILABLE. NO PROGRAMMING WAS AVAILABLE. SINCE THE PATIENT WAS IN HOSPICE, AND HAD A DNR, DECISION WAS MADE TO LEAVE DEVICE IN PLACE IN BACKUP MODE AS THAT WAS THE DESIRED PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191968 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR