BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3212530 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09190
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 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 EXPLANTED LEAD WAS DISCARDED AT THE HOSPITAL. 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 DURING A ROUTINE DEVICE FOLLOW-UP, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED PACING THRESHOLDS AND LOSS OF CAPTURE. LEAD DISLODGEMENT WAS REPORTED. AT THE LEAD REVISION PROCEDURE, THE PHYSICIAN FOUND THE LEAD TO BE COMPLETELY OUT OF POSITION AND ELECTED TO EXPLANT THE LEAD. A NEW, COMPETITIVE LEAD WAS IMPLANTED. THE PHYSICIAN BELIEVED THE DISLODGEMENT WAS DUE TO THE PATIENT'S DIFFICULT ANATOMY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312394 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R