BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VENTRICULAR & PERIOTNEAL CATHETERS WITH BACTISEAL

    MDR report key: 3232926 · Received July 18, 2013

    Report

    Report Number
    1226348-2013-21330
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 12, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK003322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE VALVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICE. THIS BIOLOGICAL DEBRIS CAUSED AN OCCLUSION IN THE DEVICE AND FOR THE RETURNED VALVE TO FAIL THE PROGRAMMING AND PRESSURE TEST, WHICH APPEARS TO HAVE CAUSED THE DIFFICULTY ENCOUNTERED BY THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. 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 SALES REP REPORTED THAT THE SHUNT STOPPED WORKING A FEW DAYS AFTER IMPLANTATION. AS A RESULT, A REVISION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336254 HAKIM VENTRICULAR & PERIOTNEAL CATHETERS WITH BACTISEAL SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 156588

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention