BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NCS LP SHUNT KIT, CLOSED TIP

    MDR report key: 1961081 · Received January 12, 2011

    Report

    Report Number
    2021898-2011-00011
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED VALVE WAS FULLY ADJUSTABLE AND ALL PERFORMANCE LEVELS COULD BE SET ON THE FIRST ATTEMPT. THEREFORE, THE COMPLAINT COULD NOT BE SUBSTANTIATED BY LABORATORY PERSONNEL. IT IS UNK WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE VALVE WAS PATENT AND PASSED LEAKAGE, SIPHON, AND REFLUX TESTING. THE VALVE PERFORMANCE MET ALL ESTABLISHED SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHUNT COULD NOT BE PROGRAMMED AFTER EXPANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA NCS LP SHUNT KIT, CLOSED TIP JXG MEDTRONIC NEUROSURGERY NA C58015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R