BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3090007 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01201
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 7, 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
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED SET SCREW ANOMALY WAS CONFIRMED IN THE LABORATORY. A TEST LEAD WAS FULLY INSERTED INTO THE RA PORT, BUT THE SET SCREW DID NOT SECURE THE TEST LEAD. THE BORE DIMENSIONS WERE MEASURED USING PIN GAUGES AND WERE FOUND TO BE WITHIN PRODUCT SPECIFICATION; HOWEVER, THE SET SCREW WOULD NOT RETAIN A MINIMUM SIZED PIN GAUGE WHEN THE SET SCREW WAS TIGHTENED. IT IS BELIEVED THAT THE CONNECTOR BLOCK WAS THE CAUSE OF THE SET SCREW ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT SETSCREW ANOMALY WAS OBSERVED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192288 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR