BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1946230 · Received December 19, 2010

    Report

    Report Number
    1946230
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 19, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO USE A PACEMAKER LEAD ON THE PATIENT. THE LEAD WAS DEFECTIVE ALTHOUGH IT IS UNKNOWN AT THIS TIME IN WHAT WAY. THERE WAS A SUCCESSFUL IMPLANTATION OF A PERMANENT PACEMAKER SYSTEM. THE PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS LEAD, PACEMAKER DTB MEDTRONIC, INC. 5076-65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR