BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 3790935 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10487
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 THE DEVICE PRESENTED A MESSAGE FOR LOST COMMUNICATION DURING A LEAD INTEGRITY TEST. MULTIPLE ATTEMPTS YIELDED THE SAME RESULTS. FURTHER EVALUATION WAS RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267486 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR