BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR DRAINAGE KIT, CLOSED TIP

    MDR report key: 2824254 · Received October 22, 2012

    Report

    Report Number
    2021898-2012-00321
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 10, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K984053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE REPORTED EVENT STATED THERE WAS A CRACK IN THE "TRANSDUCER SECTION" OF THE DRAIN. A TRANSDUCER IS AN OPTIONAL PIECE OF EQUIPMENT THAT MAY BE ATTACHED VIA THE ADAPTER TO THE INJECTION SITE OF THE PT LINE STOPCOCK. MEDTRONIC NEUROSURGERY DOES NOT SUPPLY OR MANUFACTURE TRANSDUCERS. AS THE PRODUCT WAS NOT RETURNED, IT COULD NOT BE DETERMINED IF THE DAMAGE WAS LOCATED ON THE PT LINE STOPCOCK, THE TRANSDUCER ADAPTER, OR THE TRANSDUCER. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE LUMBAR DRAIN WAS FOUND TO BE LEAKING BY THE ICU NURSE. ACCORDING TO THE REPORT, A CRACK WAS FOUND IN THE TRANSDUCER SECTION OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDM LUMBAR DRAINAGE KIT, CLOSED TIP JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 11816167

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR