BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II VR

    MDR report key: 2984528 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00589
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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 REPORTED BACK-UP VVI RESET MODE WAS CONFIRMED. THE CAUSE OF THE REPORTED BACK-UP RESET MODE AND LOSS OF COMMUNICATION WAS DUE TO BATTERY DEPLETION. A LONGEVITY CALCULATION WAS PERFORMED BASED ON PROGRAMMED SETTINGS AND USAGE DATA AND THE DEVICE WAS NOT WITHIN EXPECTED LIMITS. THE BATTERY WAS SENT TO THE MANUFACTURER AND NO ANOMALIES WERE DETECTED. THE CAUSE OF THE DEPLETION COULD NOT BE DETERMINED.

    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 PATIENT PRESENTED IN-CLINIC WITH COMPLAINTS OF SHORTNESS OF BREATH AND SLEEPLESSNESS. UPON ICD INTERROGATION, THE DEVICE WAS FOUND IN BVVI MODE. THE PATIENT DENIES BEING EXPOSED TO STRONG MAGNETIC OF HIGH VOLTAGE FIELD. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89032 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1