BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 2890135 · Received December 28, 2012

    Report

    Report Number
    2017865-2012-10799
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 4, 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 Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED LOSS OF COMMUNICATION WAS CONFIRMED IN THE LABORATORY. AS RECEIVED INTERROGATION OF THE DEVICE WAS NOT SUCCESSFUL AND THE BATTERY VOLTAGE WAS LOW. A LONGEVITY CALCULATION WAS PERFORMED BASED ON PROGRAMMED SETTINGS AND USUAGE DATA AND THE DEVICE WAS FOUND BELOW THE EXPECTED LIMITS. WITH A REPLACEMENT BATTERY, THE DEVICE TESTED NORMAL AND ALL SPECIFICATIONS WERE MET. NO SOURCES OF HIGH CURRENT DRAIN AERE FOUND. THE BATTERY WAS SENT TO THE MANUFACTURER AND AN INTERNAL BATTERY ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER NOT BEING ABLE TO TRANSMIT VIA HOUSECALL. THE CLINICIAN WAS UNABLE TO INTERROGATE THE DEVICE. BATTERY VOLTAGE WAS NORMAL. DEVICE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR