BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICP SENSOR CATHETER KIT

    MDR report key: 3941326 · Received July 17, 2014

    Report

    Report Number
    1226348-2014-11822
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 17, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FIELD.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO CODMAN; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. IN THE ABSENCE OF THE COMPLAINT SAMPLE, A LOT HISTORY RECORDS REVIEW FOR P/N 82-6633; LOT # 414996 WAS CONDUCTED, AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON SEPTEMBER 04, 2013. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT IS CONSIDERED CLOSED AT THIS TIME. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED AND THE RESPECTIVE EVALUATION PERFORMED.

    Additional Manufacturer Narrative · 1

    THE SUPPLIER PERFORMED AN EVALUATION OF THE RETURNED DEVICE AND QUALITY RECORDS. UPON COMPLETION OF THE INVESTIGATION THE REVIEW OF RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE DEVICE WAS EVALUATED AND THERE WAS NO VISIBLE DAMAGE TO THE SENSOR, CATHETER MATERIAL OR CONNECTOR. THE SENSOR PASSED ALL ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE PRODUCT PRESENTED DEFECTIVE. (DURING USE ON PATIENT). WAS REPLACED WITH SAME LIKE PRODUCT. QUESTIONS ASKED TO CUSTOMER WITH RESPONSES: 1. IS THE PRODUCT CODE CORRECT? YES. 2. WHAT WAS THE NATURE OF THE PROBLEM ASSOCIATED WITH THE DEVICE? UNK. 3. WAS THE DEVICE TUNNELED IN THE BRAIN AND REMOVED OR WAS THE PROBLEM NOTICED PRIOR TO USE? THE PRODUCT BROKE DURING HANDLING BY THE SURGEON. 4. WAS THERE A DELAY GREATER THAN 30 MINUTES? NO. 5. WERE THERE ANY ADVERSE CONSEQUENCES? NO. (B)(6) 2014, IT IS UNKNOWN WHEN THE DEVICE BROKE AS IT WAS JUST REPORTED THAT THE DEVICE BROKE DURING THE USER HANDLING. SINCE IN IT UNCLEAR IF THE DEVICE WAS IMPLANTED, THIS COMPLAINT WILL BE FILED AS A SERIOUS INJURY AS A CONSERVATIVE MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418224 ICP SENSOR CATHETER KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF 414996

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention