BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3041415 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-15070
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 15, 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. ADHESIVE TAPE ATTACHED TO CATHETER BODY. MULTIPLE KINKS AND BENDS ALONG CATHETER BODY. CATHETER MATERIAL STRETCHED 6CM FROM CONNECTOR. INTERNAL WIRES BROKEN INSIDE CATHETER AT CONNECTOR. NO TESTING WAS POSSIBLE. MFG. DATE: 6/3/11. BASED ON THE ABOVE EVALUATION, IT APPEARS THAT THE DEVICE WAS INADVERTENTLY DAMAGED BY THE CUSTOMER DURING USE. 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 THE MICROSENSOR STOPPED WORKING AFTER FEW HOURS AND A MESSAGE OF "CHECK CONNECTION" APPEARED ON SCREEN. AS A RESULT, THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143449 NEUROMONITOR BASIC KIT DEVICE, IINTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention