BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3896019 · Received June 26, 2014

    Report

    Report Number
    1226348-2014-11763
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 12, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPPLIER PERFORMED THIS EVALUATION. DURING EVALUATION A REVIEW OF THE QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: KINK IN CATHETER MATERIAL 3.6CM FROM SENSOR CASE. SUTURE ATTACHED TO CATHETER MATERIAL. THE SENSOR PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. MFG. DATE: 12/20/13. BASED ON THE ABOVE EVALUATION, THE SUPPLIER WAS UNABLE TO CONFIRM THE COMPLAINT. NO CORRECTIVE ACTION REQUIRED BASED ON THE ABOVE EVALUATION. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING SURGERY, THE VALUES INDICATED FOR INTRACRANIAL PRESSURE MEASURE WERE CHANGING. AFTER SOME TESTS WITH OTHER MONITORS, IT WAS NOTED THAT THE SENSOR WAS DEFECTIVE. THE SENSOR HAS BEEN CHANGED. INCIDENT NOT REPORTED YET. (B)(6) 2014: ADDITIONAL INFORMATION FROM CUSTOMER EXPLAINED THAT THE SENSOR WAS PLACED WHEN IT WAS NOTED. IT WAS CHANGED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373774 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF 706567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention