BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 7024307 · Received November 13, 2017

    Report

    Report Number
    1226348-2017-10825
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    October 22, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 510K # OF SIMILAR PRODUCT CODE OF (B)(4): K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF QUALITY RECORDS FOR THE COMPONENT FOUND THAT THE SENSOR MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND NO VISIBLE DAMAGE TO THE SENSOR, CATHETER MATERIAL OR CONNECTOR. 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. THE SENSOR FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF FINISHED GOOD MANUFACTURING RECORDS FOUND NO DISCREPANCIES WHEN THE DEVICE WAS RELEASED TO STOCK. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, THE SURGEON WAS UNABLE TO ZERO A MICROSENSOR AFTER IMPLANTING IT. THIS CAUSED A 30 MINUTE DELAY IN SURGERY WITH THE SURGEON FINALLY REPLACING IT WITH ANOTHER MIOCROSENSOR THAT ZEROED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804522 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. 147009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention