BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC VALVE, REGULAR, W/ BIOGLIDE

    MDR report key: 2030900 · Received March 21, 2011

    Report

    Report Number
    2021898-2011-00060
    Event Type
    Injury
    Date Received
    March 21, 2011
    Report Date
    February 26, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K033850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS PATENT AND PASSED REFLUX TESTING. THE DEVICE DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A TEAR IN THE SILICONE DOME. IT IS UNK WHEN OR HOW THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE CAUTIONS THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. IT ALSO WAS OUT OF SPECIFICATION FOR PRESSURE-FLOW TESTING AT PERFORMANCE LEVEL 2.5, 46.8 ML/HR AT 0 CM HYDROSTATIC PRESSURE. ALL OTHER PRESSURE-FLOW AND PREIMPLANTATION TESTING WERE WITHIN SPECIFICATIONS. A DISSECTION OF THE PRODUCT FOUND NO ANOMALIES. THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. NO IMPACT TO PT REPORTED. 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 PT'S SYMPTOMS DID NOT IMPROVE AFTER VALVE IMPLANTATION. ACCORDING TO THE REPORT, A CONTRAST STUDY WAS PERFORMED AND THE VALVE'S PERFORMANCE LEVEL WAS CHANGED TO 0.5, HOWEVER, THERE WAS NO IMPROVEMENT IN THE PT'S SYMPTOMS. THE PT'S CONDITION IMPROVED AFTER REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA NSC VALVE, REGULAR, W/ BIOGLIDE JXG MEDTRONIC NEUROSURGERY NA C66478

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R