MAINFRAME 8253001 NIM RESPONSE 3.0

Report

Report Number: 1045254-2013-00519
Event Type: Injury
Date Received: September 20, 2013
Date of Event: August 21, 2013
Report Date: August 23, 2013
Manufacturer: MEDTRONIC XOMED, INC.
Product Code: ETN
PMA / PMN Number: K083124
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4): 8253200 PATIENT INTERFACE RESPONSE 3.0, MFG 04/2013; SERIAL # (B)(4); LOT # 206952702. (B)(4): RECEIVED NIM 3.0 MAINFRAME AND PATIENT INTERFACE FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. A SHAKE TEST WAS PERFORMED ON THE MAINFRAME; NO LOOSE PARTS WERE HEARD. THE INTERFACE, SIMULATOR AND PROBE WERE CONNECTED AND THE MAINFRAME TURNED ON; BOOT-UP SEQUENCE COMPLETED WITH NO ERRORS. TOUCHSCREEN RESPONDED. A MONITORING MODE WAS SELECTED USING ALL AVAILABLE CHANNELS. EACH CHANNEL WAS STIMULATED IN TURN BUT NO CURRENT MEASURED TONE WAS OBSERVED. AT THAT TIME IT WAS OBSERVED THAT THE CURRENT MEASURED READING ON THE TOUCHSCREEN MATCHED THE CURRENT SETTING EVEN WHEN THE PROBE WAS NOT CONTACTING THE PATIENT SIMULATOR. NORMALLY THE CURRENT MEASURED SHOULD READ ZERO WHEN THE PROBE IS NOT IN CONTACT WITH THE PATIENT SIMULATOR. BOTH STIM1 AND STIM2 SIMULTANEOUSLY SHOWED A CURRENT MEASURED READING WHEN THE PROBE WAS NOT IN CONTACT WITH THE PATIENT SIMULATOR. THE CUSTOMER PATIENT INTERFACE WAS REPLACED WITH A TEST UNIT SUPPLIED BY SERVICE <(>&<)> REPAIR AND THEN THE SYSTEM PERFORMED NORMALLY.

Additional Manufacturer Narrative · 1

DOB (B)(6) 1952. MEDICAL RECORDS WERE RECEIVED COVERING PATIENT MEDICAL HISTORY FROM 2012-2013. REVIEW OF THE MEDICAL RECORDS IDENTIFIED PERTINENT INFORMATION RELATING TO THE REPORTED EVENT. SURGEON'S DICTATED POST-OPERATIVE NOTES DATED (B)(6) 2013 STATED THE FOLLOWING: "...TOPICAL XYLOCAINE WITH EPINEPHRINE HAD BEEN PLACED IN THE EAR CANAL DURING THE CANAL PLASTY PROCEDURE BEFORE THE TYMPANIC MEMBRANE WAS REFLECTED BUT THAT POSSIBLY XYLOCAINE ANESTHETIZED THE NERVE. THERE WAS AN AREA OF SOFT TISSUE THAT [WAS] NOTED DURING THE MASTOID OPERATION AND ALTHOUGH IT DID NOT STIMULATE IT WAS AVOIDED DURING THE REST OF THE PROCEDURE. [MY] ONLY SUSPICION IS THAT THE XYLOCAINE MAY HAVE ANESTHETIZED THE NERVE AND SURGERY IN THE REGION WAS NOT DETECTED BY THE MONITOR." PER THE NIM RESPONSE 3.0 IFU [(B)(4)] WARNINGS (P. 4): W16: IF PARALYZING ANESTHETIC AGENTS HAVE BEEN USED, PATIENT MUST REGAIN MUSCLE ACTIVITY PRIOR TO USE OF THE NIM-NEURO/RESPONSE 3.0 EMG MONITOR W20: ANESTHETIC AGENTS USED MAY HAVE AN EFFECT ON THE EMG AMPLITUDE CONTRAINDICATIONS FOR USE (P. 23): THE USE OF PARALYZING ANESTHETIC AGENTS WILL SIGNIFICANTLY REDUCE, IF NOT COMPLETELY ELIMINATE EMG RESPONSES TO DIRECT OR PASSIVE NERVE STIMULATION. WHENEVER NERVE PARALYSIS IS SUSPECTED, CONSULT AN ANESTHESIOLOGIST.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED TO CLARIFY THE EVENT: IT WAS REPORTED THAT THE PATIENT¿S FACIAL NERVE WAS INJURED DURING A MASTOIDECTOMY PROCEDURE. THE SURGEON WAS STIMULATING THE FACIAL NERVE WITH THE STIMULATION PROBE AT .08MA AND ALTHOUGH THE NERVE DEMONSTRATED REACTION, THE NERVE MONITOR WAS NOT RESPONDING PROPERLY. IT WAS NOTED THAT AUDIBLE RESPONSES WERE NOT RELIABLE TO THE SURGEON; HOWEVER, THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. POST-OPERATIVELY, THE PATIENT WAS EXAMINED AND IT WAS OBSERVED THAT THE NERVE WAS "BRUISED", BUT THE NERVE IS EXPECTED TO HAVE A FULL RECOVERY. PRODUCT ANALYSIS: THE DEVICES WERE RETURNED FOR EVALUATION BY THE QUALITY ENGINEERING GROUP. THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGE. THE EQUIPMENT WAS TESTED WITH A PATIENT SIMULATOR AND INCREMENTING PRASS PROBE. OBSERVATIONS: THE PATIENT INTERFACE, SIMULATOR AND PROBE WERE CONNECTED AND THE MAINFRAME TURNED ON; BOOT-UP SEQUENCE COMPLETED WITH NO ERRORS. TOUCHSCREEN RESPONDED. A MONITORING MODE WAS SELECTED USING ALL AVAILABLE CHANNELS. EACH CHANNEL WAS STIMULATED IN TURN BUT NO CURRENT MEASURED TONE WAS OBSERVED. AT THAT TIME IT WAS OBSERVED THAT THE CURRENT MEASURED READING ON THE TOUCHSCREEN MATCHED THE CURRENT SETTING EVEN WHEN THE PROBE WAS NOT CONTACTING THE PATIENT SIMULATOR. NORMALLY THE CURRENT MEASURED SHOULD READ ZERO WHEN THE PROBE IS NOT IN CONTACT WITH THE PATIENT SIMULATOR. BOTH STIM1 AND STIM2 SIMULTANEOUSLY SHOWED A CURRENT MEASURED READING WHEN THE PROBE WAS NOT IN CONTACT WITH THE PATIENT SIMULATOR. EXTENSIVE TESTING WAS PERFORMED ON THE MAINFRAME AND PATIENT INTERFACE BUT A ROOT CAUSE COULD NOT BE IDENTIFIED OR CONFIRMED. THE PATIENT INTERFACE WAS REPLACED WITH A TEST UNIT SUPPLIED BY SERVICE AND REPAIR DEPARTMENT AND THE SYSTEM PERFORMED NORMALLY, INDICATING A FAILURE WITH THE CUSTOMER¿S PATIENT INTERFACE; HOWEVER, A ROOT CAUSE COULD NOT BE IDENTIFIED. IN CONCLUSION, THE REPORTED COMPLAINT WAS CONFIRMED FOR FALSE NEGATIVE RESPONSE WITH AN INCONCLUSIVE ROOT CAUSE FOR THE FAILURE.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED: ON DECEMBER 21, 2015, MEDICAL RECORDS WERE RECEIVED WITH ADDITIONAL INFORMATION REGARDING PATIENT STATUS AND LATEST DOCTOR VISIT. ON (B)(6) 2015, THE PATIENT VISITED (B)(6) HOSPITAL <(>&<)> MEDICAL CENTER IN (B)(6) AND WAS SEEN BY DR. (B)(6), ANESTHESIOLOGIST, FOR A PAIN MANAGEMENT CONSULTATION. PER THE DOCTOR¿S NOTES, IT IS REPORTED THAT THE PATIENT PRESENTED WITH ¿COMPLAINT OF SYNKINESIS DYSESTHESIA, AND PAIN INTO HIS RIGHT FACE. HE IS APPROXIMATELY 2 YEARS STATUS POST TYMPANOMASTOIDECTOMY FOR CHRONIC OTITIS MEDIA ON THE RIGHT. THE PATIENT HAS GONE FROM A FLACCID PARALYSIS TO A HYPERTONIC PARALYSIS. HE OBTAINS REGULAR BOTOX INJECTIONS AND HAS HAD EXTENSIVE PHYSICAL THERAPY IN THE REGION. HE HAS SOME DISCOMFORT AND PAIN HE HAS DYSESTHESIAS OF MUSCLES CONTRACTING AND MOVING AND DISTORTING HIS FACE EVEN THOUGH THEY ARE NOT." THE PATIENT REPORTED THAT "HE FEELS A COMPRESSION CRUNCHING SPASM-TYPE DISCOMFORT. MASSAGE AND ACUPUNCTURE HAVE HELPED PARTIALLY." DR. (B)(6) ASSESSED THE PATIENT¿S CONDITION AS FOLLOWS: GENERAL APPEARANCE IS NORMAL; MUSCULOSKELETAL IS NORMAL; NEUROLOGICAL IS NORMAL; PSYCHIATRIC IS NORMAL. COMPLETE ASSESSMENT: ATYPICAL FACE PAIN; CHRONIC POSTOPERATIVE PAIN; SYNKINESIA; DYSESTHESIA OF FACE; DEPRESSION. THE PATIENT WAS PRESCRIBED LYRICA (PREGABALIN) 150MG TWICE DAILY; CYMBALTA (DULOXETINE) 30MG, ONE TIME DAILY FOR SEVEN DAYS AND THEN TWO TABLETS DAILY WITH FOOD. PATIENT MEDICAL HISTORY INCLUDES: HISTORY OF PERIPHERAL VASCULAR DISEASE; PATIENT SMOKES TWO PACKS OF CIGARETTES DAILY.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED FROM DR. (B)(6) TO CLARIFY THE EVENT: WHILE STIMULATING SOFT TISSUE IN THE MASTOID WITH THE STIMULATION CURRENT SETTING AT .8MA, THERE WAS NO AUDIBLE OR VISUAL INDICATION OF NERVE PRESENCE. ALL LEADS AND CONNECTIONS WERE CHECKED AND THE SYSTEM WAS REBOOTED BUT THE SYSTEM STILL DID NOT RESPOND AS EXPECTED; THEREFORE, NO FURTHER DRILLING WAS DONE IN THAT REGION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. POST-OPERATIVELY, THE PATIENT WAS EXAMINED AND IT WAS OBSERVED THAT THE PATIENT¿S FACE WAS PARALYZED ON THE RIGHT SIDE. THE FOLLOWING DAY, A PROCEDURE OCCURRED AT A DIFFERENT FACILITY TO RE-EXPLORE AND DECOMPRESS THE BRUISED FACIAL NERVE, WHEREBY IT WAS NOTED THAT THERE WAS A 6MM SEGMENT OF THE NERVE WHERE THE SHEATH OF THE NERVE HAD BEEN DAMAGED BY THE MASTOID DRILL. THE MAJORITY OF THE NERVE WAS INTACT AND THE NERVE STIMULATED AT VOLTAGE LEVELS THAT WERE IN THE RANGE OF 1.2MA. AT THIS POINT IN TIME THERE HAS NOT BEEN ANY RETURN OF THE FACIAL NERVE FUNCTION, BUT THERE IS EXPECTATION OF RETURN ACTIVITY OF THE FACIAL NERVE TO A HIGH LEVEL, APPROXIMATELY 90% OR BETTER.