BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 4152116 · Received October 8, 2014

    Report

    Report Number
    1226348-2014-12037
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 25, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GWM
    PMA / PMN Number
    PK991222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLES WERE NOT RETURNED TO CODMAN; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. FOR PRODUCT CODE 82-6653, THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED. THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT IS CONSIDERED CLOSED AT THIS TIME. IF THE COMPLAINT SAMPLE(S) BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. COMPLAINT SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THE SENSOR DID NOT FUNCTION. CHANGE OF SENSOR TWICE. THEY DIDN'T FUNCTION EITHER. NO CLINICAL CONSEQUENCE FOR THE PATIENT. THE SENSORS WILL BE RETURNED FOR EVALUATION. ON 9/30/2014, ADDITIONAL INFORMATION REPORTED FROM AFFILIATE: THE SURGEON WANTED TO USE A VENTRICULAR ICP KIT 82-6653. IT COULDN¿T BE CALIBRATED. HE TRIED WITH ANOTHER KIT OF SAME REFERENCE, WITHOUT SUCCESS. HE DECIDED TO USE A PARENCHYMAL ICP KIT, (B)(4), WHICH HAS CORRECTLY FUNCTIONED. IMPOSSIBLE TO CALIBRATE THE DEVICE, BEFORE INTRODUCTION IN THE PATIENT . NOT REPORTABLE. PROCEDURE COULD BE DONE WITH ANOTHER REFERENCE. ONLY 1 KIT 82-6653 WILL BE RETURNED FOR EVALUATION. ON 10/3/2014, ADDITIONAL INFORMATION REPORTED FROM AFFILIATE: THE DEVICE WAS PLACED ON A PATIENT WHO HAD A SURGERY FOR VOLUMINOUS EXTRADURAL HEMATOMA. THE CALIBRATION OF THE SENSORS WAS UNSUCCESSFUL. THE MONITOR INDICATED: ¿NON DETECTED SENSOR , VERIFY CONNECTIONS¿. THE VENTRICULAR STAYED IN PLACE AND AN INTRAPARENCHYMAL SENSOR WAS USED. IT FUNCTIONED WELL. LOST OF TIME OF 2 HOURS. FRUSTRATION AND IRRITATION OF THE MEDICAL TEAM. ON 10/6/2014, ADDITIONAL INFORMATION REPORTED FROM AFFILIATE: A DRAIN (VENTRICULAR CATHETER 82-6653) STAYED IN PLACED AND ANOTHER ICP TRANSDUCER WAS PLACED ALONG. TWO DRAINS WERE FIRST PLACED, ONE WAS REMOVED. THE MONITORING WAS NOT FUNCTIONING; 2 HOURS DELAY BEFORE TRANSFERRING THE PATIENT IN INTENSIVE CARE UNIT. NO ADVERSE CONSEQUENCE. ON 10/8/2014 EMAIL SENT TO AFFILIATE REQUESTING THE LOT NUMBER FOR THE PRODUCT THAT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630358 MICROSENSOR VENTRICULAR CATHETER KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention