BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3679972 · Received March 14, 2014

    Report

    Report Number
    1045254-2014-00061
    Event Type
    Injury
    Date Received
    March 14, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6): "WHILE THE <(><<)>PATIENT> WAS UNDERGOING SURGERY, THE NERVE INTEGRITY MOTOR ALLEGEDLY MALFUNCTIONED AND <(><<)>PATIENT>, DUE TO THE DANGEROUS, TRAPLIKE, HAZARDOUS AND DEFECTIVE CONDITION EXISTING THEREAT, SUSTAINED SEVERE, SERIOUS AND PERMANENT, PERSONAL INJURIES AS HEREINAFTER ALLEGED... THE <(><<)>PATIENT> WAS RENDERED SICK, SORE, LAME AND DISABLED AND WAS CAUSED SEVERE INJURY IN AND ABOUT HIS HEAD, BODY AND LIMBS AND EXPERIENCES GREAT PAIN AND SUFFERING. IN ADDITION, <(> <<)>PATIENT> WAS CAUSED TO SUFFER AND STILL SUFFERS GREAT PAIN, MENTAL ANGUISH, DISFIGUREMENT AND DEFORMITY AND WILL BE FORCED TO UNDER GO FURTHER MEDICAL PROCEDURES AND WAS COMPELLED TO RECEIVE EXTENSIVE MEDICAL, HOSPITAL AND OTHER CARE IN AN EFFORT TO CURE HIMSELF..."

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES ONLY. CONCOMITANT MEDICAL PRODUCTS: NIM RESPONSE 3.0 PATIENT INTERFACE (B)(4), SERIAL # (B)(4), LOT # 205396199. (B)(4): THE DEVICE WAS RETURNED FOR EVALUATION. THE MAINFRAME AND INTERFACE WERE TESTED TO PRODUCT SPECIFICATIONS; THE MAINFRAME DISPLAY TOUCH SCREEN WAS SCRATCHED AND THEREFORE, NOT WORKING PROPERLY. SOFTWARE WAS UPGRADED TO CURRENT SPECIFICATION VERSION. THE PATIENT INTERFACE WAS TESTED TO PRODUCT SPECIFICATIONS AND FOUND NO FUNCTIONAL FAULT WITH THE UNIT. THE WAVE WASHERS WERE REPLACED DUE TO A LOOSE CLIP. BOTH ITEMS WERE TESTED AND PASSED MANUFACTURER PRODUCT SPECIFICATIONS AND WERE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS POSSIBLE FACIAL PARALYSIS FOLLOWING A MIDDLE-EAR PROCEDURE. REPORTEDLY, THERE WAS A COMPLETELY DEHISCENT FACIAL NERVE SURROUNDED BY SCAR AND INFLAMMATORY TISSUE IN THE MIDDLE EAR SPACE. THE NERVE COULD NOT BE IDENTIFIED DUE TO THE SCAR TISSUE PRESENT IN THE EAR ENCASING THE NERVE. THE TISSUE WAS STIMULATED THROUGHOUT THE DISSECTION AND PRIOR TO REMOVING ANY TISSUE. EACH TIME [STIMULATION DELIVERED] THERE WAS THE CONTINUOUS SIGNAL INDICATING THE CIRCUIT WAS COMPLETE BUT NO RESPONSE WAS ELICITED TO ALERT ME THAT THE NERVE WAS WITHIN THE TISSUE BEING DISSECTED. THE SURGEON STIMULATED THE AREA WHERE THE NERVE WAS BELIEVED TO BE AND GOT NO RESPONSE [FROM THE NERVE MONITOR]. IT WAS ALSO NOTED THAT THE FACILITY HAD NO PATIENT SIMULATOR PRESENT TO TEST THE EQUIPMENT. THE PATIENT WAS REFERRED TO A NEUROLOGIST FOR NERVE DECOMPRESSION. PATIENT PROGNOSIS IS UNCERTAIN AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION AS REPORTED BY (B)(6): "WHILE THE <(><<)>PATIENT> WAS UNDERGOING SURGERY, THE NERVE INTEGRITY MOTOR ALLEGEDLY MALFUNCTIONED AND <(><<)>PATIENT>, DUE TO THE DANGEROUS, TRAPLIKE, HAZARDOUS AND DEFECTIVE CONDITION EXISTING THEREAT, SUSTAINED SEVERE, SERIOUS AND PERMANENT, PERSONAL INJURIES AS HEREINAFTER ALLEGED... THE <(><<)>PATIENT> WAS RENDERED SICK, SORE, LAME AND DISABLED AND WAS CAUSED SEVERE INJURY IN AND ABOUT HIS HEAD, BODY AND LIMBS AND EXPERIENCES GREAT PAIN AND SUFFERING. IN ADDITION, <(> <<)>PATIENT> WAS CAUSED TO SUFFER AND STILL SUFFERS GREAT PAIN, MENTAL ANGUISH, DISFIGUREMENT AND DEFORMITY AND WILL BE FORCED TO UNDER GO FURTHER MEDICAL PROCEDURES AND WAS COMPELLED TO RECEIVE EXTENSIVE MEDICAL, HOSPITAL AND OTHER CARE IN AN EFFORT TO CURE HIMSELF..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153623 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 205365243

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other| R