BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR SKULL BOLT KIT

    MDR report key: 3893577 · Received June 25, 2014

    Report

    Report Number
    1226348-2014-11748
    Event Type
    Injury
    Date Received
    June 25, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GWM
    PMA / PMN Number
    PK974088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED .

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SENSOR WAS NOT DETECTED AND THE ALARM SIGNAL OCCURRED. THE SENSOR WAS TORN OUT AND A NEW ONE WAS PLACED. THE SIGNAL ACTIVATED. CHANGE OF MONITOR, WITHOUT SUCCESS. A THIRD SENSOR WAS USED WITH THE FORMER MONITOR. IT HAS FINALLY FUNCTIONED. THE INCIDENT HAS NOT BEEN REPORTED TO THE (B)(6). (B)(6) 2014 CUSTOMER REPORTED: THE FIRST AND SECOND SENSORS WERE IMPLANTED AND THEN REMOVED. THE FIRST ONE WAS TORN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED: NOTE THAT ONLY ONE OF THE TWO NON-FUNCTIONAL MICROSENSORS WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370242 MICROSENSOR SKULL BOLT KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention