BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2780969 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13194
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE. A CHEST X-RAY WAS PERFORMED AND CONFIRMED THAT THE LEAD HAD DISLODGED INTO THE RIGHT VENTRICLE. THE RIGHT VENTRICULAR AND ATRIAL FUNCTIONALITY WAS NOT IMPAIRED AND ALL OTHER MEASUREMENTS WERE NORMAL. A REVISION PROCEDURE WAS PERFORMED; THE LEFT VENTRICULAR LEAD WAS REMOVED, SUCCESSFULLY REPLACED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R