BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 3130073 · Received May 21, 2013

    Report

    Report Number
    2021898-2013-00183
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. ALL VALUES ARE 100% TESTED AT THE TIME OF MANUFACTURE. ADDITIONAL PATIENT/DEVICE INFORMATION: MEDTRONIC CHINA CUSTOMER SERVICE PROVIDED THE PATIENT'S MOTHER WITH THE CONTACT INFORMATION FOR TWO NEUROSURGEONS IN THEIR AREA TO CHECK THE STATUS OF THE VALVE AND READJUST ITS SETTINGS IF NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A STRATA WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2013 IN (B)(6) HOSPITAL. AFTER THE SURGERY, THE VALVE WAS ADJUSTED TO PRESSURE-LEVEL 2.0. FIVE DAYS AFTER THE SURGERY, THE VALVE WAS ADJUSTED TO PRESSURE-LEVEL 1.5. RECENTLY, THE PATIENT'S MOTHER FOUND A "DEEP PIT" ON THE PATIENT'S HEAD. SHE WANTED TO KNOW IF THE VALVE WAS OVERDRAINING AT PRESSURE-LEVEL 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225530 UNKNOWN STRATA VALVE/SHUNT JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR