BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 2860501 · Received December 5, 2012

    Report

    Report Number
    2021898-2012-00404
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    August 27, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. THE VALVE DID NOT MEET REQUIREMENTS FOR THE SIPHON, REFLUX, PREIMPLANTATION, AND LEAKAGE TESTINGS. IT ALSO DID NOT MEET ALL OF THE REQUIREMENTS FOR THE PRESSURE-FLOW TESTINGS. THERE WAS A SMALL TEAR ON THE TOP OF THE RESERVOIR CHAMBER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY PERITONEAL CATHETER BROKE AND THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A NEW STRATA SYSTEM. IT WAS ALSO REPORTED THAT THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II VALVE, REGULAR JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R