BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2212555 · Received August 11, 2011

    Report

    Report Number
    1226348-2011-00305
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE 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: SEALANT IS LIFTING AT ONE END OF THE SENSOR CASE. CATHETER IS SEVERELY KINKED 3CMS FROM CASE. CATHETER IS MASHED 10CMS FROM CONNECTOR. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THE ABOVE EVALUATION, THE SUPPLIER WAS UNABLE TO CONFIRM THE COMPLAINT. NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR 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

    REP REPORTED THAT THE ICP MICROSENSOR WIRE DID NOT FUNCTION PROPERLY. THERE WERE NO OTHER DETAILS AVAILABLE. IT IS NOT CLEAR IF THIS EVENT WAS PATIENT RELATED. THERE WAS NO RECORD OF WHAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC., MEDOS S.A. NA CLPBCM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention