BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2210347 · Received August 9, 2011

    Report

    Report Number
    1226348-2011-00301
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 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
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. CODMAN BARCODE LABELS ARE DISCOLORED. MARKINGS (507) ON ONE SIDE OF CONNECTOR. THREE CUTS IN CATHETER MATERIAL 48CMS FROM CASE. MULTIPLE MASHED AREAS ALONG CATHETER BODY. DEVICE FAILED ELECTRICAL LEAKAGE TEST - INTERNAL SPEC. EQUAL OR LESS THAN 3UA; TEST READING = 3.45UA. 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 OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE ICP MEASURING WAS NOT ACCURATE. AS A RESULT, THE DEVICE WAS REVISED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention