BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 3130074 · Received May 21, 2013

    Report

    Report Number
    2021898-2013-00184
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE CAUTIONS THAT DEVICES KNOWN TO CONTAIN MAGNETS SHOULD BE KEPT AWAY FROM THE IMMEDIATE VALVE IMPLANT LOCATION, AS THEY MAY HAVE AN EFFECT ON THE PERFORMANCE LEVEL SETTING OF THE STRATA-TYPE VALVE. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PATIENT STATED IN (B)(4) THAT SHE WOKE UP WITH A LOW PRESSURE HEADACHE. SHE CLAIMED THAT IT FELT LIKE HER VALVE HAD ADJUSTED ITSELF AGAIN. SHE REPORTED THAT HER VALVE WAS READJUSTED TWO WEEKS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225345 UNKNOWN STRATA VALVE/SHUNT JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR