BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 2242444 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06624
    Event Type
    Injury
    Date Received
    September 10, 2011
    Date of Event
    June 16, 2011
    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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND THAT THE OUTPUT CIRCUITRY OF THE DEVICE WAS DAMAGED. IT IS BELIEVED THE LEADS ARCED TO THE CAN CAUSING A LOW IMPEDANCE PATH THAT RESULTED IN DAMAGE TO THE OUTPUT CIRCUITRY. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED SYSTEM. ALL LOW VOLTAGE DEVICE FUNCTIONS WERE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE INTERROGATION REVEALED ONE CHARGE THAT WAS INTERRUPTED DUE TO POSSIBLE HIGH VOLTAGE DAMAGE. THE PATIENT WAS ADMITTED AND THE ICD AND LEAD WERE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1570/65, (B)(4)