BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3223476 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10775
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 CHANGES IN SENSING AND PACING THRESHOLD WERE NOTICED ON BOTH RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS DURING ROUTINE FOLLOW UP CHECKUP. THE LEADS WERE FOUND TO BE DISLODGED ON X-RAY EXAMINATION; THEREFORE, A REPOSITIONING PROCEDURE WAS DONE AND THE LEADS WERE SUCCESSFULLY REPOSITIONED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323117 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R