BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2170945 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09837
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    September 27, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A PROCEDURE TO REMOVE A COMPETITOR RIGHT ATRIAL LEAD DUE TO LOW PACING IMPEDANCES AND INSULATION DAMAGE THE RIGHT VENTRICULAR LEAD WAS EXTRACTED WITH A LASER TO ASSURE NO DAMAGE WAS SUSTAINED TO THIS LEAD DURING THE REMOVAL OF THE RIGHT ATRIAL LEAD. DIFFICULT WAS ENCOUNTERED REMOVING THE RIGHT VENTRICULAR LEAD, AND A PART OF THE LEAD REMAINED IN THE HEART. ANOTHER PROCEDURE TO REMOVE THE PORTION OF THE LEAD LEFT IN THE PATIENT WAS SCHEDULED FOR A LATER DATE. THE EXPLANTED PORTION OF THE LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1