BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1812183 · Received August 17, 2010

    Report

    Report Number
    2021898-2010-00189
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE WAS PATENT, BUT DID NOT PASS LEAK TESTING DUE TO TEARS ON THE TOP AND SIDE OF THE DELTA CHAMBER. THE VALVE DID NOT MEET SPECIFICATIONS FOR SIPHON AND REFLUX TESTING, AS WELL AS PRESSURE FLOW CHARACTERISTICS AT -50 CM HP, DUE TO DAMAGE TO THE DELTA CHAMBER. THE VALVE WAS WITHIN SPECIFICATIONS FOR ALL OTHER PRESSURE-FLOW 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. IT IS ALSO SUGGESTED 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 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 A VALVE APPEARED TO BE LEAKING CSF FROM THE SIDE, AND REQUIRED A REPLACEMENT. THE EVENT OCCURRED INTRAOPERATIVE WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL JXG MEDTRONIC NEUROSURGERY NA C58119

    Patients

    Seq Age Sex Outcome Treatment
    1