MAINFRAME 8253001 NIM RESPONSE 3.0

Report

Report Number: 1045254-2013-00598
Event Type: Injury
Date Received: December 12, 2013
Date of Event: October 28, 2013
Report Date: November 20, 2013
Manufacturer: MEDTRONIC XOMED, INC.
Product Code: ETN
PMA / PMN Number: K083124
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE FINDINGS OF THE PRODUCT ANALYSIS ARE NOT AVAILABLE AS THE DEVICE WAS NOT RETURNED. NO TESTING METHODS PERFORMED.

Additional Manufacturer Narrative · 1

THIS SUPPLEMENTAL IS BEING SUBMITTED TO ADD THE PRODUCT'S SERIAL NUMBER AND RELATED INFORMATION. NO OTHER ADDITIONAL INFORMATION HAS BEEN RECEIVED. MAINFRAME 8253001 NIM RESPONSE 3.0, MODEL NUMBER: 8253001, SERIAL NUMBER: (B)(4). DEVICE MANUFACTURE DATE: NOV. 17, 2013.

Additional Manufacturer Narrative · 1

LOT NUMBER: 205528756. THE 510K: K083124. MANUFACTURE DATE: NOV. 17, 2011.

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 THE SURGEON HAD A QUESTION ABOUT WHY SHE WAS GETTING AN EMG RESPONSE WHEN SHE WAS NOT DOING ANY ACTIVE MONITORING. THIS WAS CONCLUDED TO BE ARTIFACT FROM THE ROOM. ON FURTHER DISCUSSION, IT WAS NOTED THAT THE CASE CONCLUDED WITH AN UNINTENTIONALLY SEVERED NERVE. THE DOCTOR KNEW THE NERVE WAS CUT, WAS NOT ATTEMPTING TO MONITOR IT, AND DID NOT INTEND TO IMPLICATE THE NIM IN THE INJURY WHEN ASKING QUESTIONS ABOUT THE ARTIFACT. HOWEVER, THIS IS REPORTED AS AN ADVERSE EVENT SINCE A MEDTRONIC PRODUCT WAS IN USE IN A CASE WHERE A PATIENT WAS INJURED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
649704	MAINFRAME 8253001 NIM RESPONSE 3.0	STIMULATOR, NERVE	ETN	MEDTRONIC XOMED, INC.	8253001	205528756

Patients

Seq	Age	Sex	Outcome	Treatment
1			Disability