BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2151727 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06129
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD WAS RETURNED TO OUR QUALITY ASSURANCE LABORATORY. VISUAL INSPECTION NOTED SET SCREW MARKS ON TERMINAL PIN AND RING AND BOTH TINES REMAINED INTACT AT DISTAL TIP OF LEAD. THE LEAD FAILED THE STYLET INSERTION TEST DUE TO DRIED BLOOD IN THE LUMEN. HOWEVER, RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD MAY HAVE DISLODGED AS IT HAD MEASURED HIGH THRESHOLDS AND PRODUCED MUSCLE STIMULATION. NO FURTHER EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 4542| 4086| N119| 0184