BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II PLUS DR

    MDR report key: 1223708 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03542
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 8, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP910023
    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 FIELD EXPERIENCE OF A SETSCREW ANOMALY WAS VERIFIED IN THE LABORATORY. VISUAL INSPECTION OF THE DEVICE HEADER REVEALED THAT ALL THE SEPTA WERE DAMAGED. THE HEX CAVITIES WERE FILLED WITH SEPTUM DEBRIS, PREVENTING FULL INSERTION OF THE TORQUE DRIVER. THE SETSCREW BECAME STRIPPED WHEN PRESSURE WAS APPLIED TO TIGHTEN IT. WITH THE NEW SETSCREWS, A TEST LEAD COULD BE TIGHTENED D TO THE PROPER TORQUE IN THE A AND V-BORES, AND NORMAL LEAD IMPEDANCE WAS MEASURED. NO OTHER ANOMALIES WERE OBSERVED.

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR SURGICAL PROCEDURE TO HIGH LEAD IMPEDANCE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE SETSCREW WAS NOT TIGHTENED DOWN. THE DEVICE WAS EXPLANTED WHEN THE RING AROUND THE SETSCREW CAME OFF DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention