BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA

    MDR report key: 2153091 · Received June 17, 2011

    Report

    Report Number
    2021898-2011-00133
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT AND PASSES SIPHON TESTING. HOWEVER, IT DID NOT MEET SPECIFICATIONS FOR REFLUX OR LEAK TESTING AS THERE WERE TEARS IN THE SIDE AND TOP OF THE DELTA CHAMBER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE DEVICE MET ALL REQUIREMENTS FOR PRESSURE/FLOW AND PRE-IMPLANTATION TESTS. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVE AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. IT IS ALSO SUGGESTS THAT THE VALVE BE PLACED IN A SURGICALLY CREATED LOOSE SUBGALEAL POCKET. THIS ALLOWS GENTLE PLACEMENT OF THE VALVE AND MINIMIZES HANDLING WITH SURGICAL TOOLS. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. NO IMPACT TO THE PT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT ALLEGEDLY A STRATA VALVE TAKEN OFF THE SHELF WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C76642

    Patients

    Seq Age Sex Outcome Treatment
    1