BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF - SHUNT KIT, CONTOURED VALVE, REGULAR, LOW PRESSURE

    MDR report key: 2891234 · Received December 21, 2012

    Report

    Report Number
    2021898-2012-00447
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    August 17, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT PASSED REFLUX, LEAK, PRESSURE-FLOW AND PRE-IMPLANTATION TESTING. THE VENTRICULAR AND PERITONEAL CATHETER PASSED PATENCY AND LEAK TESTING. THEREFORE THE CONDITIONS OF THE COMPLAINT COULD NOT BE VERIFIED BY LABORATORY PERSONNEL. IT IS UNKNOWN WHAT CAUSED THE REPORTED EVENT. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR 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 BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION OR OTHER DEBRIS." A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. ALL OF OUR CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER CONNECTING THE DEVICES INTRAOPERATIVELY, THE PHYSICIAN FOUND THAT THE FLUID DRAINAGE WAS INADEQUATE. ACCORDING TO THE REPORT, THE PHYSICIAN CHANGED THE DEVICE TO COMPLETE THE OPERATION. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF - SHUNT KIT, CONTOURED VALVE, REGULAR, LOW PRESSURE JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C79841

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR