BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CATHETER

    MDR report key: 2384779 · Received November 18, 2011

    Report

    Report Number
    2021898-2011-00282
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 1, 2011
    Report Date
    October 25, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT DID NOT GIVE DETAILED INFO REGARDING THE ALLEGED EVENT OR SPECIFIC PRODUCT INVOLVED. FURTHER, IT COULD NOT BE CONFIRMED THAT THE PRODUCT FROM THE REPORT IS MANUFACTURED BY MEDTRONIC NEUROSURGERY. TO DATE, REQUESTS FOR ADD'L INFO HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER ALLEGEDLY SHEARED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CATHETER JXG - SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1