BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2241748 · Received September 9, 2011

    Report

    Report Number
    1226348-2011-00338
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    June 29, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS INVESTIGATION AND DURING THE EVALUATION, A REVIEW OF THE QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: THE CATHETER AND WIRES HAVE BEEN STRETCHED AND BROKEN AT THE NECK OF THE CONNECTOR. INTERNAL CATHETER WIRES EXPOSED. NO TESTING POSSIBLE. BASED ON THE ABOVE EVALUATION, IT APPEARS THAT THE DEVICE WAS INADVERTENTLY DAMAGED BY THE CUSTOMER. NO FURTHER ACTIONS ARE REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE 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. PLEASE NOTE THAT THIS REPORT IS BEING FILED LATE AS A RESULT OF A REPORTING DELAY TO THE U.S. FROM THE AFFILIATE COUNTRY. THE REPRESENTATIVE WAS COUNSELED AND IS AWARE OF THE REPORTING REQUIREMENTS. DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT IT WAS FOUND THAT THE MICROSENSOR WOULD MOVE AT TIMES. THE CONNECTOR WAS TAPED BY THE HOSPITAL AND WHEN TAPED IT WORKED. AFTER THE DEVICE STOPPED WORKING THE SENSOR WAS EXAMINED BY THE HOSPITAL AND FOUND THAT THE WIRE WAS EXPOSED. PLEASE NOTE THAT THE ALERT DATE AS WELL AS THE EVENT DATE MAY BE IN ACCURATE. MORE INFORMATION IS EXPECTED AND WILL BE REPORTED IN THE FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN AND SHURTLEFF - MEDOS 11097664

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention