BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR-C

    MDR report key: 2984346 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00601
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 21, 2013
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED RELIABILITY LABORATORY TECHNICIAN; (B)(6). NO COMPLAINT RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. AN OUTPUT ANOMALY WAS OBSERVED IN THE LABORATORY. ANALYSIS FOUND A DAMAGED COMPONENT WITHIN THE OUTPUT CIRCUITRY. THE CAUSE OF THE OUTPUT ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87040 ATLAS PLUS VR-C IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-193C NA

    Patients

    Seq Age Sex Outcome Treatment
    1