BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3030536 · Received April 2, 2013

    Report

    Report Number
    1226348-2013-14726
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS EVALUATION. DURING THE 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: COSMETIC LIFTING OF SEALANT AT SENSOR AREA. SLIGHT BENDS ALONG CATHETER BODY. THE SENSOR PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. MFG. DATE: 04/28/11. BASED ON THE ABOVE EVALUATION, SUPPLIER WAS UNABLE TO CONFIRM THE COMPLAINT. NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT AFTER THE PATIENT WAS IN THE MRI, THE ICP MICROSENSOR WOULD NOT SHOW VALUES ANY LONGER. AFTER CONNECTING THE SENSOR WITH THE ICP EXPRESS MONITOR, THE SENSOR REQUESTED A NEW ZEROING. A NEW DEVICE WAS USED BUT THE ACCESS WAS THE SAME. NO ADDITIONAL MEDICAL INTERVENTION FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135031 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention