FDA Adverse Event Malfunction Summary report: N

NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

MDR report key: 5752481 · Received June 27, 2016

Report

Report Number: 1045254-2016-00208
Event Type: Malfunction
Date Received: June 27, 2016
Date of Event: June 2, 2016
Report Date: June 2, 2016
Manufacturer: MEDTRONIC XOMED INC.
Product Code: ETN
PMA / PMN Number: K112686
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT NUMBER - 8253001 (MAINFRAME, NIM RESPONSE 3.0); SERIAL NUMBER - (B)(4); LOT NUMBER: 66965800; MANUFACTURED DATE ¿ APRIL 5, 2010; 510K ¿ K083124. THE 8229705 (EMG TUBE): THE DEVICE WAS DISCARDED BY THE CUSTOMER. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. THE 8253001 (NIM 3.0 MAINFRAME): THE DEVICE IS STILL IN USE BY THE CUSTOMER AND WILL NOT BE RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A THYROID RESECTION, USING A TRIVANTAGE TUBE, THE USER WAS STIMULATING THE NERVE, BUT WAS NOT GETTING A CONSISTENT EMG RESPONSES. THE SURGEON STATED THAT THE NIM DID NOT RESPOND WITH THE APPROPRIATE SOUND WHEN THEY PUT THE PROBE ON THE NERVE, EVEN THOUGH THEY COULD VISUALLY SEE THE NERVE. AFTER THE CASE, THE DOCTOR SUSPECTED THAT THE TUBE WAS IN THE WRONG PLACE AS THE PATIENT HAD DIFFICULT ANATOMY. THERE WAS APPROXIMATELY A FIVE MINUTE DELAY TO THE CASE. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
405176	NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®	STIMULATOR, NERVE	ETN	MEDTRONIC XOMED INC.	8229705

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR