BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486

    MDR report key: 5591271 · Received April 20, 2016

    Report

    Report Number
    1226348-2016-10312
    Event Type
    Injury
    Date Received
    April 20, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DATE HAS BEEN UPDATED TO REFLECT MANUFACTURE OF THE SPECIFIC COMPONENT ASSOCIATED WITH THIS COMPLAINT BY THE SUPPLIER. IT WAS INITIALLY REPORTED AS THE DATE THE COMPLETED KIT WAS RELEASED. THE SENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND ADHESIVE TAPE ON THE CATHETER AND BLACK MARKING "485" WRITTEN ON THE CONNECTOR LABEL. THE DEVICE PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. BASED ON THEIR EVALUATION, THE SUPPLIER WAS UNABLE TO CONFIRM THE REPORTED ISSUE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    IT HAD BEEN REPORTED THAT THE DEVICE WOULD NOT BE MADE AVAILABLE FOR EVALUATION. SUBSEQUENT TO THIS REPORT, THE DEVICE WAS RETURNED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. IT WAS LATER COMMUNICATED THAT THE DEVICE WOULD NOT BE MADE AVAILABLE. THIS REPORT HAS BEEN UPDATED WITH THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND FOUND NO DISCREPANCIES WHEN THE DEVICE WAS RELEASED TO STOCK. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    FOR SIMILAR PRODUCT CODE OF 826638: 510 (K) #K974088. (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE SENSOR HAS FUNCTIONED CORRECTLY DURING A FEW DAYS BEFORE SHOWING NEGATIVE VALUES OR UNUSUAL FLUCTUATION . THE ZEROING PROCEDURE WAS CORRECT AND DIFFERENT ICP MONITORS WERE TESTED WHEN THE VALUES WERE FALSE. NO CLINICAL CONSEQUENCE. PATIENT RISK IF THE MONITORING HAS TO BE CHANGED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245246 ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486 DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. CTKCCN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention