BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 2984612 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00598
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 12, 2012
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOSS OF COMMUNICATION WAS CONFIRMED DUE TO LOW BATTERY VOLTAGE. A LONGEVITY CALCULATION WAS PERFORMED BASED ON PROGRAMMED SETTINGS AND USAGE DATA AND THE DEVICE WAS NOT FOUND TO MEET ITS LONGEVITY REQUIREMENT. WITH THE REMOVAL OF THE BATTERY AND AN EXTERNAL POWER SUPPLY CONNECTED, COMMUNICATION OF THE DEVICE WAS SUCCESSFULLY ESTABLISHED. THE DEVICE TESTED NORMALLY AND NO SOURCES OF HIGH CURRENT DRAIN WERE DETECTED. THE BATTERY WAS SENT TO THE MANUFACTURING FACILITY AND NO ANOMALIES WERE DETECTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR NORMAL FOLLOW-UP. SEVERAL ATTEMPTS WERE MADE TO INTERROGATE THE DEVICE; HOWEVER, NO COMMUNICATION COULD BE ACHIEVED. THE PATIENT HAS INTRINSIC RHYTHM. THE NEXT DAY, THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS GOOD AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85869 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1