BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1861016 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15232
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    November 25, 2009
    Report Date
    July 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE LEAD WAS RETURNED AND THE ALLEGATION COULD NOT BE CONFIRMED BY TESTING AND ELECTRONICALLY THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S THRESHOLDS ON THIS LEAD HAD INCREASED. THERE WAS REPORT OF ON-GOING PACING DURING THRESHOLD TESTING. IT WAS LATER REPORTED THAT THIS LEAD HAD DISLODGED. NO PATIENT EFFECTS WERE REPORTED.

    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 71 YR Required Intervention 0158| N118| 4470| 4518