BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS DR

    MDR report key: 3090022 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01277
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 8, 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 Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF A DEVICE RESET WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER ON RESET. FURTHER ANALYSIS FOUND THAT THERE WAS A DAMAGED COMPONENT WITHIN THE HIGH VOLTAGE CIRCUITRY. THE CAUSE OF THE POWER ON RESET COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A CARDIOVERSION PROCEDURE. INTERROGATION REVEALED THE DEVICE WAS IN HARDWARE BACK-UP VVI MODE WITH NO THERAPY AVAILABLE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192409 ATLAS PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-243 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention