BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II SHUNT, REGULAR, BIOGLIDE

    MDR report key: 2960331 · Received February 7, 2013

    Report

    Report Number
    2021898-2013-00040
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 20, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K060681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PATIENT SEEKING TREATMENT FOR HEADACHE, DIZZINESS, AND VOMITING WAS DIAGNOSED WITH HYDROCEPHALUS AND HAD THE STRATA II SHUNT IMPLANTED ON (B)(6) 2012. THE REPORT STATES THAT A CT SCAN PERFORMED DURING THE INITIAL VISIT SHOWED THAT THE PATIENT HAD CANCER AND ALSO CONFIRMED THE HYDROCEPHALUS DIAGNOSIS. IT WAS STATED IN THE REPORT THAT THE VALVE WAS INITIALLY SET TO PL 1.5 AND THAT THE PATIENT APPEARED TO BE RECOVERING OKAY. ACCORDING TO THE REPORT, 2 MONTHS AFTER HAVING THE DEVICE IMPLANTED THE PATIENT EXPERIENCED UNDER-DRAINAGE AND HIGH INTRACRANIAL PRESSURE. THE REPORT THEN STATES THAT THE PATIENT WENT TO THE HOSPITAL IN (B)(6) 2012, AND WAS GIVEN THE DIAGNOSIS OF DEVICE SYNECHIA AND PLUGGING IN THE ABDOMINAL END. ALLEGEDLY, AT THE TIME OF THE HOSPITAL VISIT THE PHYSICIAN DID THE SYNECHIA CLEANING AND ADJUSTED THE VALVE TO PL 1.5 IN (B)(6) 2012 THE PATIENT REPORTEDLY RETURNED TO THE HOSPITAL AFTER FEELING DIZZY AND HAD CT SCANS PERFORMED WHICH SUGGESTED THAT THE PATIENT'S VENTRICLES APPEARED COMPRESSED. REPORTEDLY THE PHYSICIAN FELT THE PATIENT WAS BEING OVER-DRAINED AND ADJUSTED THE VALVE TO PL 2.0. THE REPORT GOES ON TO STATE THAT IN DECEMBER 2012 THE PATIENT HAD ANOTHER CT SCAN PERFORMED AFTER COMPLAINING OF EXPERIENCING HEADACHE AND DIZZINESS. THE REPORT STATES THAT THE DECEMBER CT SCAN SHOWED THAT THE PATIENT'S VENTRICLES WERE STILL COMPRESSED, AND THAT THE PHYSICIAN ADJUSTED THE VALVE TO PL 2.5. IT IS THEN ALLEGED THAT ON (B)(6) 2013 THE PATIENT RETURNED TO THE HOSPITAL AFTER EXPERIENCING HEADACHES AND DIZZINESS, AND WERE ONCE AGAIN IMAGED VIA CT SCAN WHERE IT WAS OBSERVED THAT THEIR VENTRICLES AND COMPRESSED EVEN MORE. AT THAT TIME, THE REPORT GOES ON TO SAY, THE PHYSICIAN CONSIDERED THAT THE SHUNT MAY HAVE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51835 STRATA II SHUNT, REGULAR, BIOGLIDE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D12914

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR