BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1760563 · Received July 14, 2010

    Report

    Report Number
    2021898-2010-00141
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 21, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE VALVE WAS PATENT, BUT IT DID NOT PASS LEAK TESTING DUE TO TEARS ON THE RESERVOIR. THIS PRECLUDED SIPHON AND REFLUX TESTING AS WELL AS MEASUREMENT OF PRESSURE FLOW CHARACTERISTICS AND PREIMPLANTATION TESTING. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE CAUTIONS THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO IMPROVEMENT IN SYMPTOMS, AND THE VALVE WAS REPLACED. THE PATIENT RECOVERED AFTER REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL JXG MEDTRONIC NEUROSURGERY NA C53293

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R