BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP ATRIAL LEAD

    MDR report key: 1012984 · Received February 25, 2008

    Report

    Report Number
    1012984
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 25, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE IMPEDANCE OF THE ATRIAL LEAD WAS FOUND TO BE LOW. INTRAOPERATIVELY THE LEADS WERE FOUND DENSELY ADHERENT TO THE FIBROUS CAPSULE OF THE POCKET AND WERE DISSECTED FREE. IT WAS NOTICED IMMEDIATELY THAT THERE WAS SOME ARCING OF THE ELECTROCAUTERY TOWARD ONE OF THE LEADS. THIS WAS LATER IDENTIFIED AS THE ATRIAL PACING ELECTRODE. IT HAD A VISIBLE INSULATION BREAK AT THIS POINT. IN ADDITION IT WAS ALSO FOUND TO HAVE MORE PROXIMAL INSULATION BREAKS IN THIS LEAD. FOR THIS REASON, IT WAS ELECTED TO REMOVE BOTH OF THE LEADS AT THIS TIME. THE NEED FOR AN ANTERIOR THORACOTOMY HAD BEEN DISCUSSED WITH THE PATIENT PREOPERATIVELY TO INSERT A VENTRICULAR EPICARDIAL PACING ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP ATRIAL LEAD LEAD, PACEMAKER, ATRIAL DTB MEDTRONIC, INC. IS-1B1 *
    2 CAPSURE Z ATRIAL LEAD LEAD, PACEMAKER, ATRIAL DTB MEDTRONIC, INC. IS1UNI88CM *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR