BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS II PLUS DR

    MDR report key: 3210586 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03544
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 11, 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 Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED HEADER ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING A ROUTINE DEVICE CHANGE-OUT DUE TO ERI, THE HEADER HAD TO BE DISSECTED APART TO REMOVE THE RV LEAD THAT WAS STUCK IN THE HEADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309297 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR