BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2171542 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10375
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    April 12, 2011
    Report Date
    July 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD REVEALED THE COILS WERE COMPRESSED 19 CENTIMETERS (CM) FROM THE TERMINAL PIN. A CUT IN THE INSULATION WAS ALSO NOTED 39.5 CM AND 57 CM FROM THE TERMINAL PIN. THE DAMAGE OBSERVED LIKELY OCCURRED DURING THE EXPLANT PROCEDURE. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS OF THE CONDUCTIVE PATHS WERE WITHIN NORMAL LIMITS. PRESSURE TESTS WERE NOT SUCCESSFUL DUE TO THE CUTS IN THE LEAD INSULATION. MICROSCOPIC INSPECTIONS OF THE ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR PACING LEAD EXHIBITED LOSS OF CAPTURE. A DECREASE IN PACING IMPEDANCE MEASUREMENTS AND AMPLITUDE MEASUREMENTS WAS ALSO OBSERVED. A LEAD REVISION WAS PERFORMED AND FLUOROSCOPY SHOWED THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED, SUCCESSFULLY REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention 4518| 4135| N118| 0184