BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 3010797 · Received March 19, 2013

    Report

    Report Number
    1226348-2013-14064
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE NEUROSURGEON HAD TO REVISE THE VALVE WITHIN ONE WEEK DUE TO LIMITED FLOW THROUGH THE VALVE. THE OPERATING ROOM WAS VERY UPSET THAT THEY HAD TO REPLACE THE VALVE WITHIN ONE WEEK OF INITIAL PLACEMENT. THE SURGEON WAS NOT SURE AS TO WHAT CAUSED THE LIMITED FLOW. HE INDICATED THAT THE CATHETERS APPEAR TO BE UNOBSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114695 CERTAS INLIN VLV SPHN/UNIT CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention