BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 559392 · Received January 12, 2004

    Report

    Report Number
    559392
    Event Type
    Malfunction
    Date Received
    January 12, 2004
    Date of Event
    October 23, 2003
    Report Date
    December 9, 2003
    Manufacturer
    MEDTRONIC EP SYSTEMS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE TO IMPLANT A BIVENTRICULAR DEFIBRILLATOR LEAD WIRE, THE GUIDE WIRE BROKE OFF IN THE SUBCLAVIAN VEIN. THE BROKEN WIRE WAS SUCCESSFULLY RETRIEVED USING A SNARE. THERE WAS NO PATIENT INJURY, BUT THE PROCEDURE TIME WAS INCREASED BY SEVERAL HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC GUIDEWIRE DQX MEDTRONIC EP SYSTEMS NTLPLS 180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR