BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR CATHETER, 80CM, BARIUM IMPREGNATED

    MDR report key: 1882808 · Received October 13, 2010

    Report

    Report Number
    2021898-2010-00253
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE CATHETER WOULD NOT THREAD THROUGH THE TUOHY NEEDLE. THE CATHETER TIP SHEERED OFF WHEN BOTH UNITS WERE WITHDRAWN FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDM LUMBAR CATHETER, 80CM, BARIUM IMPREGNATED JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization