BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC VALVE, REGULAR

    MDR report key: 1930711 · Received December 14, 2010

    Report

    Report Number
    2021898-2010-00350
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K033850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS PATENT, BUT IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO MULTIPLE TEARS IN THE SILICONE DOME ABOVE THE RESERVOIR. IT IS UNK HOW OR WHEN THESE DAMAGES OCCURRED. THERE WERE ALSO SCRATCHES ON THE BASE OF THE RESERVOIR, BELOW THE TEARS. THEREFORE, IT IS POSSIBLE THAT THE DAMAGES OCCURRED WHEN INJECTING OR CSF SAMPLING FROM THE VALVE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE NOTE THAT INJECTION OR CSF SAMPLING THROUGH THE DOME IS ALLOWED BY USE OF A 25-GAUGE OR SMALLER NON-CORING NEEDLE. IT IS ALSO CAUTIONED THAT "LOW TEAR STRENGTH IS A CHARACTERISTIC OF UNREINFORCED SILICONE ELASTOMER MATERIALS. CARE MUST BE TAKEN ON INSERTION AND REMOVAL OF THE NEEDLE." THE VALVE DID NOT MEET THE REQUIREMENTS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. PROTEINACEOUS DEBRIS WAS NOTED IN THE VALVE MECHANISM. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN OVERDRAINAGE AND REFLUX. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. NO PT IMPACT WAS REPORTED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER THE SURGERY, THE PT'S SYMPTOMS HAD NOT IMPROVED, AND SUBCUTANEOUS FLUID WAS FOUND BY A CT SCAN. ON (B)(6) 2010, THE PT HAD A REVISION SURGERY AND THE DOCTOR FOUND THE RESERVOIR HAD A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA NSC VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY NA C53173

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R CATALOG# 91503, LOT# C60995| CATALOG# 93522, LOT# C64800