IT WAS REPORTED ?DURING THE FACIAL NERVE DECOMPRESSION SURGERY USING THE PAIRED ELECTRODES, THE MUSCLE HAD A RESPONSE BUT IT WAS NOT SHOWN IN THE NIM. THE PROCEDURE WAS REPORTEDLY CONTINUED WITHOUT TAKING ANY ACTION FOR THIS INCIDENT, AND COMPLETED WITH NO DELAY OR ADVERSE EFFECT.? FOLLOW-UP COMMUNICATION OBTAINED ADDITIONAL INFORMATION: IT WAS NOTED THAT THE ISSUE MAY HAVE BEEN RELATED TO HOW THE ELECTRODES WERE PLACED BUT THE DOCTOR BELIEVES IT IS RELATED TO A PROBLEM WITH THE 2 CHANNEL ELECTRODES. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.
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Patient 1
(B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4), NIM RESPONSE 2.0 MAINFRAME LOT/SERIAL # UNKNOWN. (B)(4): THE DEVICE HAS BEEN RECEIVED AND PRODUCT ANALYSIS IS ANTICIPATED BUT NOT YET BEGUN. METHOD ? NO TESTING METHODS PERFORMED. (B)(4).
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Patient 1
THE DEVICE WAS RETURNED AND EVALUATED BY A QUALITY ENGINEER. RECEIVED 1 SAMPLE(S), PART NUMBER 8227410. EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS), MULTIMETER. OBSERVATIONS: WHEN COMPARED TO THE ASSEMBLY DRAWING FOR PAIRED SUBDERMAL ELECTRODE DRAWING: END TO END RESISTANCE FOR EACH SIDE OF THE PAIRED ELECTRODES SHALL BE
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Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.