BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 2982891 · Received February 25, 2013

    Report

    Report Number
    2021898-2013-00063
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    September 14, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MFR. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE, A REVIEW OD THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS FOUND TO BE BROKEN DURING THE SURGERY, AND THAT IT WAS REPLACED WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78998 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 12282817

    Patients

    Seq Age Sex Outcome Treatment
    1