BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHY SM8A KIT PREATTACHED / BO19-10

    MDR report key: 3170745 · Received May 22, 2013

    Report

    Report Number
    3001587388-2012-00413
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    August 3, 2012
    Report Date
    May 21, 2013
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS SHOWED THAT THE SM8A-2010 VALVE IS NOT BLOCKED OFF AND MEETS ALL ITS REQUIREMENTS WITHIN THE LABORATORY CONDITIONS OF TESTING. UNFORTUNATELY, SINCE THE VALVE WAS CLEANED BEFORE RETURN, IT IS DIFFICULT TO EXPLAIN THE INCIDENT. SINCE THE NEUROSURGEON CHECKED THE NON PATENCY OF THE SHUNT BY VISUAL EXAM OF THE DISTAL CATHETER IN THE PERITONEUM, LACK OF DRAINAGE CAN BE EXPLAINED BY A FEW HYPOTHESIS: INTRACRANIAL PRESSURE LESS THAN THE VALVE PRESSURE SETTING OF THE VALVE, OBSTRUCTION IN THE VENTRICULAR CATHETER, MOVING OF THE VENTRICULAR CATHETER IN THE PLEXUS CHOROID OR OUTSIDE OF THE VENTRICLE, OBSTRUCTION OF THE VALVE (NOT CONFIRMED BY SOPHYSA WITH THE CLEANED RETURNED DEVICE). SHUNT OBSTRUCTION IS A KNOWN COMPLICATION MENTIONED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THE DOCTOR HAS REQUESTED PROGRAMMER TO PERFORM AN EMERGENCY INTERVENTION IN THE PATIENT, WHICH WAS READY FOR THE PROCEDURE. THE DOCTOR DID ZEROING VALVE AFTER OPENING THE ABDOMEN AND DID SEVERAL TESTS AND FOUND THAT THE VALVE HAD NOT A GOOD PERFORMANCE. THE DOCTOR DID REMOVE THE VALVE AND DID WASHES WITH SERUM BUT WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226986 SOPHY SM8A KIT PREATTACHED / BO19-10 SOPHY SM8A KIT PREATTACHED JXG SOPHYSA SA SOPHY Y0485

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK