BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3050124 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03534
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 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

    THIS LEAD WAS SURGICALLY ABANDONED; AVAILABLE INFORMATION INDICATES THE NEW LEAD REMAIN IN SERVICE WITHOUT FURTHER COMPLICATION. 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 (LV) LEAD EXHIBITED INCREASED PACING THRESHOLDS THREE DAYS POST-IMPLANT. DISLODGEMENT WAS CONFIRMED. IT WAS NOTED THAT DURING THE IMPLANT PROCEDURE, THE LV LEAD PLACEMENT HAD NOT BEEN OPTIMAL. A NEW ACCESS WAS MADE, AND A NEW LEAD WAS IMPLANTED. DURING THE PROCEDURE, THE NEW LEAD PULLED BACK SLIGHTLY AFTER THE POCKET WAS CLOSED. LEAD MEASUREMENTS REMAINED ACCEPTABLE, AND NO FURTHER ACTION WAS TAKEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS TO REMAIN HOSPITALIZED TO ENSURE THE LV LEAD REMAINED IN POSITION; IF NOT, THE PATIENT WOULD BE CONSIDERED FOR AN EPICARDIAL LV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148883 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R