BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3070391 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06497
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 18, 2013
    Report Date
    May 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS RETURNED AND IS CURRENTLY IN ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE COMPLETE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD SHOWED DRIED BLOOD/BODY FLUID IN THE LUMEN. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING NORMAL DEVICE CHANGE OUT, THIS LEAD WAS ATTEMPTED AS A SECOND LEAD FOLLOWING OUT OF RANGE MEAUSREMENTS, NOISE AND A LOSS OF CAPTURE (LOC) OF THE FIRST ATTEMPTED LEAD. THIS LEAD ALSO DISPLAYED OUT OF RANGE IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THIS LEAD WAS NOT IN A STABLE POSITION AT THE TIME. BOTH LEADS WERE EXPLANTED AND A THIRD LEAD WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172241 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0157| T127| 4469