BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2 VALVE, REGULAR

    MDR report key: 2852886 · Received November 27, 2012

    Report

    Report Number
    2021898-2012-00397
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT; IT MET THE REQUIREMENTS FOR REFLUX AND SIPHON TESTING. IT ALSO MET THE SPECIFICATIONS FOR LEAK TESTING. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. IT IS UNKNOWN WHAT CAUSED THE REPORTED VENT. THE DEVICE MET ALL SPECIFICATIONS FOR PRESSURE-FLOW AND PREIMPLANTATION TESTING WITH THE EXCEPTION OF PRESSURE-FLOW TESTING AT -50 CM HP. PROTEINACEOUS DEBRIS WAS OBSERVED ON THE INTERIOR AS WELL AS THE EXTERIOR OF 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 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." A REVIEW OF MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS FOUND TO BE LEAKING DURING SURGERY. ACCORDING TO THE REPORT, ANOTHER SET WAS USED TO COMPLETE THE SURGERY. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2 VALVE, REGULAR JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D26080

    Patients

    Seq Age Sex Outcome Treatment
    1