BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNNELING TOOL WITH EXTENSION CARRIER

    MDR report key: 4643384 · Received March 20, 2015

    Report

    Report Number
    MW5041679
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 20, 2015
    Manufacturer
    MEDTRONIC, INC
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CONE-LIKE PLASTIC TIP OF THE PLASTIC SHEATH FOR THE TUNNELER BROKE OFF INSIDE THE PATIENT'S NECK DURING TUNNELING. THE TIP WAS UNABLE TO BE LOCATED BY O-ARM, ULTRASOUND, OR MANUAL EXPLORATION BY SURGEON. PLEASE NOTE - TIP IS NOT DETECTABLE BY X-RAY. REASON FOR USE: SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191941 TUNNELING TOOL WITH EXTENSION CARRIER TUNNELER HAO MEDTRONIC, INC 365538 N519648

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR