BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2201832 · Received August 5, 2011

    Report

    Report Number
    1226348-2011-00298
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 10, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS COMPLAINT WAS EVALUATED BY THE SUPPLIER. 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. THREE CUTS IN CATHETER MATERIAL 14CMS FROM SENSOR CASE. MULTIPLE SEVERE KINKS, MASHED, AND STRETCHED AREAS ALONG CATHETER. CODMAN CONNECTOR LABEL TORN AND MISSING TEXT. WIRES BROKEN INSIDE CATHETER. UNABLE TO TEST. BASED ON THE ABOVE EVALUATION, IT APPEARS THAT THE DEVICE WAS INADVERTENTLY DAMAGED BY THE CUSTOMER. 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 DEVICE WAS IMPLANTED AND AFTER FOUR HOURS IT STOPPED WORKING. AS A RESULT A REVISION WAS CONDUCTED.

    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 CLBCJC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention