BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1901199 · Received November 9, 2010

    Report

    Report Number
    1901199
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDTRONIC NEURO
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT INDICATED THAT HIS INFUSION PUMP WAS NO LONGER RELIEVING HIS PAIN. WHEN AN EXPLORATION WAS DONE, BLOOD WAS FOUND IN THE CATHETER AND THE CONNECTOR BETWEEN THE CATHETER AND THE PUMP. THE CONNECTOR WAS REPLACED AND THE CATHETER WAS RECHECKED FOR PATENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SUTURELESS CONNECTOR LKK MEDTRONIC NEURO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR