BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1944580 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20035
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS LEFT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE. THE FRACTURE WAS ATTRIBUTED TO A FINISHING WIRE THAT HAD BEEN CUT AND ABANDONED INSIDE THE LEAD AT IMPLANT 15.6 MONTHS PREVIOUS. THE LEAD AND WIRE WERE CUT INTO FOUR PIECES DURING THE EXPLANT PROCEDURE AND SUBSEQUENTLY DISCARDED AT THE EXPLANTING FACILITY. THE PATIENT ALSO HAD ANOTHER MANUFACTURER'S SUBCUTANEOUS LEAD ARRAY EXPLANTED DURING THE SAME PROCEDURE DUE TO A FRACTURE.

    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 66 YR Required Intervention 4543| N119| 0185| 4136| (B)(4)