BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1950440 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22445
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS EXPLANTED LV LEAD WAS DISCARDED BY THE HOSPITAL STAFF AND WILL NOT BE RETURNED FOR LABORATORY TESTING. 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 FROM AN IMPLANT FORM THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY DUE TO LEFT VENTRICULAR (LV) DISLODGEMENT. ATTEMPTS TO REPOSITION THE LV LEAD WAS UNSUCCESSFUL. A REPLACEMENT LEAD WAS IMPLANTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R MISMATCH| 4518| 4076| H125