BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 3552294 · Received January 6, 2014

    Report

    Report Number
    1226348-2014-10202
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    August 30, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. IT IS POSSIBLE THAT THE PROBLEM WAS LIKELY DUE TO AN EXCESSIVE FLOW RATE (>0.75 ML/MIN) DURING THE FLUSHING PROCEDURE WHICH ACTIVATES THE SIPHON GUARD AND CREATES THE IMPRESSION THAT THE VALVE IS DISTALLY OCCLUDED. IN REALITY THE FLOW IS BEING DIVERTED TO THE HIGH RESISTANCE SECONDARY PATHWAY, THIS WILL SLOW THE RATE AT WHICH CSF IS SHUNTED FROM THE BRAIN. IT WOULD PROBABLY EXPLAIN THE PROBLEM ENCOUNTERED BY THE CUSTOMER BUT THIS COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE DOCTOR WANTED TO IMPLANT 82-3162 CODMAN HYDROCEPHALUS VALVE WITH INTEGRATED SIPHON GUARD BUT DURING THE PRIMING PROCEDURE, NO STERILE SALINE SOLUTION CAME OUT OF THE VALVE DISTALLY. THE DOCTOR SAID HE EXPERIENCED AN ABNORMAL HIGH COUNTER PRESSURE HE NEVER HAD BEFORE WITH THIS TYPE OF HYDROCEPHALUS VALVE AND AS A RESULT OF THIS, THE DOCTOR IMPLANTED ANOTHER 82-3162 THAT WAS IN STOCK IN THE PHARMACY DEPT OF THE HOSPITAL. WITH THIS SECOND 82-3162 THINGS WENT AS NORMAL. THERE WAS A 5 MIN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7881 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPGB8B

    Patients

    Seq Age Sex Outcome Treatment
    1