BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR DRAINAGE KIT OPEN TIP

    MDR report key: 2970134 · Received February 15, 2013

    Report

    Report Number
    2021898-2013-00054
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K862303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER THE LUMBAR CATHETER WAS IMPLANTED, THE PHYSICIAN FOUND IT TO BE LEAKING. THEY THEN CUT THE LEAKING PORTION OF THE CATHETER OFF AND RE-IMPLANTED THE DEVICE. DUE TO THE SHORT SIZE OF THE CATHETER, POSTOPERATIVE MANAGEMENT WAS DIFFICULT. IT WAS ALSO REPORTED THAT THERE WAS NO INJURY TO THE PT. AT THE TIME OF THE REPORT THE PT WAS STILL UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66582 EDM LUMBAR DRAINAGE KIT OPEN TIP JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 11883622

    Patients

    Seq Age Sex Outcome Treatment
    1