MAINFRAME 8253001 NIM RESPONSE 3.0

Report

Report Number: 1045254-2013-00601
Event Type: Injury
Date Received: December 16, 2013
Date of Event: August 14, 2013
Report Date: November 21, 2013
Manufacturer: MEDTRONIC XOMED, INC
Product Code: ETN
PMA / PMN Number: K083124
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL DEVICES: FUSE KIT: 8253075 NIM 3.0 PAT INTFC 32MA, K083124, SERIAL #: (B)(4), MANUFACTURE DATE: UNKNOWN. ENDOTRACHEAL TUBE: 8229307 NIM EMG 7MM RE, 510K: K925640, MANUFACTURE DATE: UNKNOWN. PROBE 8225825 3PK INCREMT STD PRASS TIP, 510K: K934426, MANUFACTURE DATE: UNKNOWN. (B)(4). THE DEVICE IS NOT EXPECTED TO BE RETURNED. THEREFORE NO PRODUCT ANALYSIS IS AVAILABLE. METHOD: NO TESTING METHODS 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 RIGHT HEMITHYROIDECTOMY, THE SURGEON STATED THAT HE WAS GETTING EMG WAVEFORMS ON CHANNEL 1, BUT WASN¿T GETTING ANY WAVEFORM TECHNOLOGY FROM THE RIGHT SIDE. HE BELIEVES HE SAW THE RLN ON THE RIGHT SIDE AND STIMULATED IT, BUT GOT NO RESPONSE. THE SURGEON STATES THE NIM ENDOTRACHEAL TUBES WERE PLACED PROPERLY AT INTUBATION. PATIENT¿S RIGHT VOCAL CORD WAS NOT WORKING POST OP. THE REPORT STATES THAT THE PRODUCT WILL NOT BE RETURNED TO MANUFACTURER. THE REP HOOKED UP A PATIENT SIMULATOR TO THE NIM SOON AFTER THE EVENT, AND STATED, ¿EVERYTHING CHECKED OUT PERFECTLY.¿ IN FOLLOW-UP THE DOCTOR STATED THAT THE EMG TUBES WERE DISCARDED, AND THE PATIENT¿S VOCAL CORD IS STILL NOT MOVING SINCE SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
655973	MAINFRAME 8253001 NIM RESPONSE 3.0	STIMULATOR, NERVE	ETN	MEDTRONIC XOMED, INC	8253001	65139500

Patients

Seq	Age	Sex	Outcome	Treatment
1	00059 YR		Required Intervention\| S