BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 6107469 · Received November 16, 2016

    Report

    Report Number
    2021898-2016-00415
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    November 20, 2015
    Report Date
    October 17, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    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. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    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 FOLLOWING IMPLANT, THE PATIENT DEVELOPED AN INTRACRANIAL INFECTION. ACCORDING TO THE REPORT, THE DEVICE WAS EXPLANTED AND LATER REPLACED WITH A NEW DEVICE. REPORTEDLY, THE PATIENT WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756407 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R