BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2911881 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00485
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    May 17, 2011
    Report Date
    December 5, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 LEAD WAS REPORTED TO HAVE FRACTURED APPROXIMATELY TWENTY MONTHS AGO. THE FRACTURE HAD BEEN NOTED ON A CHEST X-RAY. RECENTLY, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED. A REPLACEMENT LEAD WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19104 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4542| 0184| T175| MISMATCH| H210