BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 7036775 · Received November 16, 2017

    Report

    Report Number
    1226348-2017-10846
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 24, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510K # OF SIMILAR PRODUCT CODE OF 826631: K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE WERE UNSUCCESSFUL. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO PRODUCT OR LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A MICROSENSOR DISLAYED INCONSISTENT READINGS DURING THE IMPLANT PROCEDURE. IT WAS REPLACED BY ANOTHER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM. SERIAL LOT IS UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816947 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1