BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2170314 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09970
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LABORATORY ANALYSIS REVEALED THAT THE COMPLETE LEAD WAS RETURNED. THERE WERE NO IRREGULARITIES OBSERVED AT TIP SECTION OF LEAD. BOTH TINES REMAINED INTACT. RESISTANCE AND PRESSURE TESTS VERIFIED THE ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY OF THE LEAD. THE CLINICAL OBSERVATION WAS UNABLE TO BE REPRODUCED DURING LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED DISLODGEMENT ONE DAY POST IMPLANT. AT THIS TIME THE TYPE OF INTERVENTION HAS NOT BEEN DECIDED BY THE PHYSICIAN. ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT WAS EXPLANTED AND A NEW PRODUCT WAS PLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT WAS RETURNED FOR LABORATORY 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 71 YR Required Intervention E110| N119| 4542| 4591| 4136| 0185