BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 6126259 · Received November 23, 2016

    Report

    Report Number
    2021898-2016-00434
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    July 21, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS POST-OPERATIVELY IN MEDICALLY STABLE CONDITION. IT WAS UNKNOWN IF PAST REVISIONS INVOLVED THE MANUFACTURER¿S PRODUCTS. PATIENT INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. REFER TO REPORT (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE MALFUNCTIONED CAUSING THE PATIENT TO HAVE INCREASED HYDROCEPHALUS AND ASSOCIATED SYMPTOMS. THE PATIENT EXPERIENCED THREE DAY PROGRESSIVE CONFUSION, HEADACHE, AND GAIT INSTABILITY. THE VALVE WAS EXPLANTED AND REPLACED. IT WAS NOTED THE PATIENT HAD A HISTORY OF REVISIONS, INCLUDING A REPLACEMENT OF A VALVE IN 1992.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775230 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R