BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTS INLIN VLV W/UNIT BAC CAT

    MDR report key: 3040359 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-14965
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE 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

    AFFILIATE REPORTED THAT THE PATIENT DEVELOPED SUBCUTANEOUS SWELLING. IT WAS ALSO NOTED THAT THE DEVICE MAY NOT HAVE BEEN FIXED WITH SUTURES. AS A RESULT OF THE SWELLING, THE DEVICE WAS REPROGRAMMED. AT THE PRESENT TIME, NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE SWELLING IS DISAPPEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143991 CERTS INLIN VLV W/UNIT BAC CAT SHUNT, CENTRAL NERVOUS SYSTEM, & COMPS JXG CODMAN & SHURTLEFF, INC. CNKBOY

    Patients

    Seq Age Sex Outcome Treatment
    1