BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3043196 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02219
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE WITHOUT FURTHER COMPLICATIONS. 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 TEN DAYS POST IMPLANT, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A CHANGE IN THE WAVEFORM ON THE ELECTROGRAM (EGM). NO CAPTURE WAS OBTAINED AT 7.5V. AN X-RAY CONFIRMED THE LEAD WAS DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED INTO ANOTHER TARGET VESSEL. THE PHYSICIAN BELIEVED THE INITIAL POSITION OF THE LEAD WAS POOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146552 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R