BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 6096195 · Received November 11, 2016

    Report

    Report Number
    2021898-2016-00408
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. THE VALVE MET THE REQUIREMENTS FOR SIPHON, REFLUX, PRESSURE-FLOW, AND PREIMPLANTATION TESTING. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR AND EXTERIOR OF THE VALVE. THE INSTRUCTIONS FOR USE (IFU) THAT ACCOMPANY THE DEVICE CAUTION THAT SHUNT OBSTRUCTION MAY OCCUR IN ANY OF THE COMPONENTS OF THE SHUNT SYSTEM. THE SYSTEM MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION, OR OTHER DEBRIS. THE RETURNED VALVE ALSO DID NOT MEET REQUIREMENTS FOR LEAK TESTING DUE TO A TEAR OBSERVED IN THE TOP OF THE DELTA CHAMBER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE IFU CAUTION 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 WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY REPORTED THE DEVICE WAS IMPLANTED ON (B)(6) 2008. ACCORDING TO THE REPORT, THE DEVICE WAS FOUND TO BE OVERDRAINING AND WAS EXPLANTED ON (B)(6) 2016. THE REPORT STATED THAT UPON EXPLANTATION, THE DEVICE APPEARED TO HAVE A LEAK FROM A HOLE IN THE DELTA CHAMBER. REPORTEDLY, THE PATIENT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746105 UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R