BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2173862 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10871
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 18, 2011
    Report Date
    August 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THE COILS WERE SLIGHTLY STRETCHED AT THE TIP REGION OF THE LEAD; NOTED TO LIKELY BE DUE TO HANDLING DAMAGE AT EXPLANT. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY OF THE LEAD. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED THRESHOLDS AND QUESTIONED THE MARKER TIMING. TECHNICAL SERVICES (TS) DISCUSSED DIFFERENT LEAD CONFIGURATIONS AND SENSING, NOTING THAT THE MARKER TIMING INDICATED THAT THE LEAD WAS SENSING ATRIAL ACTIVITY AND THAT THE LEAD MAY HAVE MOVED. TS RECOMMENDED AN X-RAY AS WELL AS PROGRAMMING OPTIONS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD HAD DISLODGED INTO THE PATIENT'S ATRIUM AND A REVISION WAS PERFORMED, DURING WHICH THE LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE LEAD WAS LATER RETURNED FOR ANALYSIS.

    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| 4135| N119| 0184