BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA SHUNT KIT REGULAR, PL 1.5

    MDR report key: 1930698 · Received December 14, 2010

    Report

    Report Number
    2021898-2010-00348
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    September 20, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    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 AND PASSED SIPHON AND REFLUX TESTING. 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 DEVICE PERFORMANCE DID NOT MEET ESTABLISHED SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. PROTEINACEOUS DEBRIS WAS NOTED ON THE VALVE MEMBRANE. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN, RESULTING IN OVERDRAINAGE. 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 ONE WEEK AFTER THE SURGERY, THE PT FELT UNCOMFORTABLE. A CT REVIEW FOUND A SMALL AMOUNT OF FLUID AROUND THE VALVE, AND THE VENTRICLES WERE ENLARGED. THE DOCTOR PERFORMED A SECOND SURGERY AND FOUND THAT THE RESERVOIR WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA SHUNT KIT REGULAR, PL 1.5 JXG MEDTRONIC NEUROSURGERY NA C66509

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R