BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2041814 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01604
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 14, 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

    ANALYSIS IS CURRENTLY ONGOING. ONCE ANALYSIS IS COMPLETE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PROXIMAL PORTION OF THE LEAD WAS RETURNED, SEVERED 608 MILLIMETERS FROM THE TERMINAL PIN. ANALYSIS CONFIRMED A FRACTURE AT 100 - 110 MM FROM THE TERMINAL PIN AND 397 - 410 MM FROM THE TERMINAL PIN. ADDITIONAL DAMAGE WAS NOTED AT THE SAME LOCATIONS, INCLUDING DEFORMED CONDUCTOR COILS, A BREACH IN BOTH THE INNER AND OUTER INSULATION, AS WELL AS DEFORMATION OF THE OUTER INSULATION. A THIRD FRACTURE SITE WAS FOUND 486 MM FROM THE TERMINAL PIN WITH ONE OF THE COIL WIRES FRACTURED. DUE TO THE RETURNED CONDITION OF THE LEAD, ROUTINE MECHANICAL AND ELECTRICAL TESTING WAS UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    SUBSEQUENTLY THIS LEAD WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO HIGH PACING IMPEDANCES. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention 4555| 4543| 0185| N119| H177| 4471