BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STRATA VALVE

    MDR report key: 1900164 · Received October 22, 2010

    Report

    Report Number
    2021898-2010-00263
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WERE NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    WIFE HAD STRATA IMPLANTED IN 2003. VALVE WAS SET TO PL 2.5. PATIENT DID WELL FOR 4 YEARS OR MORE. THE PATIENT STARTED HAVING WALKING DIFFICULTIES RECENTLY AND IS BEING TREATED BY ANOTHER DOCTOR. VALVE HAS BEEN AT EVERY PL SETTING AND NONE SEEM TO MAKE ANY DIFFERENCE IN TERMS OF GAIT. THEY ARE SEEING THE NEUROSURGEON NEXT WEEK. SURGEON MAY REMOVE DEVICE, AS THERE IS SOME QUESTION AS TO WHETHER IT IS FUNCTIONING OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRATA VALVE JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK