BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, SMALL, BIOGLIDE

    MDR report key: 3830350 · Received May 23, 2014

    Report

    Report Number
    2021898-2014-00172
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 27, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT MET THE REQUIREMENTS FOR LEAK TESTING, PREIMPLANTATION AND PRESSURE-FLOW TESTING AT 0 CM HYDROSTATIC PRESSURE (HP). HOWEVER, THE VALVE DID NOT MEET THE REQUIREMENTS FOR SIPHON, REFLUX OR PRESSURE FLOW TESTING AT -50 CM HP. THERE WAS PROTEINACEOUS DEBRIS OBSERVED IN THE INTERIOR AND EXTERIOR OF THE DEVICE. DEBRIS WITHIN THE DEVICE MAY INTERFERE WITH THE SIPHON CONTROL DEVICE RESULTING IN FLUID SIPHONING AND / OR REFLUX. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF THE VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT UNDERWENT VP SHUNT IMPLANTATION IN 2007 AT THE AGE OF ONE, TO BE TREATED FOR AQUEDUCT STENOSIS. ACCORDING TO THE REPORT, THERE WAS CONTINUOUS FOLLOW-UP WITH THE VALVE SET AT PERFORMANCE LEVEL 2.0. THE REPORT STATED THAT CT SCANS WERE PERFORMED ON THE PATIENT IN STAGES, WITH WHICH BLOOD TUMORS WERE FOUND IN THE RIGHT SIDE OF HIS HEAD. REPORTEDLY, THE PL WAS INCREASED TO 2.5 IN RESPONSE TO THIS. ACCORDING TO THE REPORT, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO OVER DRAINAGE. THE REPORT STATED THAT THE DEVICE WAS REPLACED WITH A COMPETITOR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308016 STRATA II VALVE, SMALL, BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R