BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2212557 · Received August 11, 2011

    Report

    Report Number
    1226348-2011-00306
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    PATIENT SENT FOR MRI USING 3 TESLA WITH MICROSENSOR IN-SITU. THE MICROSENSOR WAS DISCONNECTED FROM THE TRANSDUCER CABLE AND COILED JUST PRIOR TO MRI. WHEN THE MRI WAS COMPLETED, ON REMOVING PATIENT FROM THE MRI MACHINE, IT WAS NOTED THAT THE MICROSENSOR TRANSDUCER END WAS DETACHED FROM THE CATHETER AND COULD NOT BE FOUND NEAR OR IN THE MRI MACHINE. FOLLOWING THIS SURGEON REMOVED THE CATHETER FROM THE PATIENT, HOWEVER DISCARDED THIS. UNFORTUNATELY AS THE TRANSDUCER END OF THE MICROSENSOR COULD NOT BE FOUND, NEITHER PIECE OF THE TRANSDUCER COULD BE SENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC., MEDOS S.A. NA CLNC14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention