BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1864238 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16271
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    July 14, 2010
    Report Date
    September 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD THIS LEAD GET RETURNED, IT WOULD BE ANALYZED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION OF THIS LEAD CONFIRMED BOTH FIXATION TINES REMAIN IN TACT AT THE DISTAL TIP OF THE LEAD. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN AND RING ASSEMBLY. THE LEAD PASSED RESISTANCE, HIPOT AND PRESSURE TESTING VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE AND BOTH INNER AND OUTER INSULATION INTEGRITY. THE STYLET INSERTION TEST WAS NOT COMPLETED SUCCESSFULLY DUE TO DRIED BLOOD IN THE TIP REGION OF THE LUMEN. LABORATORY TESTING WAS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD WOULD NOT CAPTURE IN ALL CONFIGURATIONS. DECREASED R-WAVES AND IMPEDANCE WERE ALSO NOTED. AN X-RAY CONFIRMED CHANGE IN LEAD POSITION. THE DEVICE WAS PROGRAMMED TO RV PACE ONLY. NO ADVERSE PATIENT EFFECTS REPORTED, HOWEVER THE PATIENT DID HAVE SYMPTOMS OF FATIGUE. ONE MONTH LATER, WE RECEIVED NEW INFORMATION THAT THIS LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

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    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 65 YR Required Intervention 0181| N119| 4076| 4542