BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAMR VALVE, REGULAR

    MDR report key: 5949205 · Received September 14, 2016

    Report

    Report Number
    2021898-2016-00321
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 16, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K152700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT. THE VALVE MET THE REQUIREMENTS FOR SIPHON, AND REFLUX TESTING. ALL PERFORMANCE LEVELS COULD BE SET WITH A SINGLE ATTEMPT, AND THE VALVE DID NOT SPONTANEOUSLY CHANGE LEVELS DURING THE COURSE OF ANALYSIS. HOWEVER, THE DEVICE DID NOT MEET REQUIREMENTS FOR PRESSURE FLOW, AND PREIMPLANTATION TESTING. THERE WAS PROTEINACEOUS DEBRIS OBSERVED WITHIN THE INTERIOR AND EXTERIOR OF THE VALVE. DEBRIS WITHIN THE VALVE MAY HOLD PRESSURE-FLOW CONTROLLING MECHANISMS OPEN AFFECTING THE FLOW OF FLUID THROUGH THE VALVE. THE INSTRUCTIONS FOR USE 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 DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE A TEAR OBSERVED IN THE TOP OF THE DELTA CHAMBER. 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.¿ 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 VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT TESTING IS IN PROGRESS. 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.¿ 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 VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS FOUND TO BE LEAKING FROM THE DELTA CHAMBER INTRAOPERATIVELY. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. REPORTEDLY, THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602379 STRATAMR VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY E12266

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR