BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 1831065 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03641
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 17, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND THE DEVICE IN BACKUP VVI MODE DUE TO A DISCREPANT HV CAPACITOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 311 MG/DL ON ADVANTAGE SYSTEM 1, 119 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT, THE PROGRAMMER SHOWED AN ALERT MESSAGE BACKUP VVI MODE. IT WAS NOT POSSIBLE TO REPROGRAM THE DEVICE. THE DEVICE WAS EXPLANTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention