BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTS INLIN VLV W/UNIT BAC CAT

    MDR report key: 3040341 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-14972
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 23, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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 AFFILIATE REPORTED THAT THE DEVICE MAY NOT HAVE BEEN SUTURED. DUE TO THE CURLING OF THE DEVICE BEHIND THE EAR AND A SIGNIFICANT AMOUNT OF SWELLING THAT OCCURED, RESULTED IN AN EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142802 CERTS INLIN VLV W/UNIT BAC CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CNMDNJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention