BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS DR

    MDR report key: 2984328 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00606
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 13, 2012
    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 Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A DEVICE RESET WAS CONFIRMED IN THE LABORATORY. IT WAS NOTED THAT THE BATTERY VOLTAGE DROPPED QUICKLY IN THE TWO MONTHS BEFORE THE REPORTED EVENT. THE POWER ON RESET WAS CAUSED BY THE LOW BATTERY VOLTAGE. THE BATTERY WAS FOUND TO BE WITHIN OVERALL ESTIMATED LONGEVITY, BUT THE REASON FOR THE VOLTAGE DROP IN THE MONTHS BEFORE THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO ER WITH BRADYCARDIA. AT INTERROGATION, DEVICE WAS SHOWN TO BE IN HARDWARE RESET MODE. DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88107 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR