BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 4101587 · Received September 19, 2014

    Report

    Report Number
    1226348-2014-11981
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 7, 2014
    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

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE REPORTED UNDER THIS COMPLAINT: P/N 82-6631; S/N (B)(4) - RETURNED TO CODMAN FOR EVALUATION. P/N 82-6631; S/N (B)(4) - RETURNED TO CODMAN FOR EVALUATION. P/N 82-6631; S/N UNK. - NOT RETURNED TO CODMAN FOR EVALUATION. P/N 82-6635; S/N (B)(4) - NOT RETURNED TO CODMAN FOR EVALUATION. P/N 82-6635; S/N (B)(4) - NOT RETURNED TO CODMAN FOR EVALUATION. S/N (B)(4). 1 - NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL OR CONNECTOR. 2 - THE SENSOR PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. MFG. DATE: 9/9/13. A REVIEW OF QUALITY RECORDS WAS CONDUCTED FOR BOTH MICROSENSORS AND PRIOR TO DISTRIBUTION BOTH DEVICES MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. BASED ON THE ABOVE EVALUATION, SUPPLIER WAS UNABLE TO CONFIRM THE COMPLAINT. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. COMPLAINT IS CONSIDERED CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: PATIENT RETURNED TO THEATRE FOR ICP MONITOR TO BE CHANGED (LE3382), AS THE ICP WAS RANGING IN MEASUREMENT OVERNIGHT. NEW ICP MONITOR (LE10302) AND MICRO SENSOR WERE USED. THE SENSOR WAS ZEROED CORRECTLY, SUTURED AND CLOSED. THE ICP RANGED FROM 10 ? 22 MMGH. SURGEON WAS CONCERNED ABOUT THE RANGE OF THE ICP READING AND CHANGED OVER TO ANOTHER ICP (LE3751) AND NEW MICRO SENSOR. THE SENSOR ZEROED, THE ICP READING INITIALLY FLUCTUATED THEN READ -99. DUE TO THIS THE SURGEON WAS STILL CONCERNED AND PLACED IN AN EVD. (DURING USE ON PATIENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584312 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. CPLCCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention