BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDIUM PRESSURE FLOW CONTROL VALVE

    MDR report key: 3040142 · Received April 3, 2013

    Report

    Report Number
    2021898-2013-00119
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. 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 OF OUR VALUES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    THE REVIEW LITERATURE ARTICLE CONTAINED A CASE REPORT FOR A PT WHO HAD BEEN PREVIOUSLY DIAGNOSED WITH TRI-VENTRICULAR HYDROCEPHALUS, AND WHO HAD A VENTRICULOPERITONEAL SHUNT IMPLANTED AS PART OF THEIR TREATMENT. THE ARTICLE STATED THAT THE PT WAS ADMITTED WITH A COMPLAINT OF SEVERE HEADACHES THREE YEARS AFTER THE SHUNT WAS IMPLANTED AND A BIFRONTAL CALCIFIED/OSSIFIED EPIDURAL HEMATOMA (EDH) WAS SEEN. ACCORDING TO THE ARTICLE, THE EDH WAS COMPLETELY REMOVED SURGICALLY AND THE PT WAS ASYMPTOMATIC WHEN THEY WERE DISCHARGED. THE ARTICLE ALSO STATED THAT THE HEADACHES RESOLVED COMPLETELY, AND THAT THERE WERE NO COMPLAINTS OR NEUROLOGICAL FINDINGS AND THAT THEIR SHUNT WAS FUNCTIONING 36 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136302 UNKNOWN MEDIUM PRESSURE FLOW CONTROL VALVE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization