BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 2950103 · Received February 8, 2013

    Report

    Report Number
    2938836-2013-00073
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 4, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OUTPUT ANOMALY WAS VERIFIED IN THE LABORATORY. A REVIEW OF THE DIAGNOSTICS DATA INDICATED ABORTED CHARGES DUE TO OUTPUT CIRCUIT DAMAGE. DURING ANALYSIS DAMAGE TO THE HIGH VOLTAGE OUTPUT CIRCUITRY WAS OBSERVED. THE CAUSE OF DAMAGED REMAINS UNDETERMINED.

    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 DURING A FOLLOW UP, DEVICE INTERROGATION REVEALED POSSIBLE OUTPUT CIRCUIT DAMAGE WITH MULTIPLE ABORTED SHOCKS. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54168 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR 7000/65, (B)(4)