MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® PROBE; STIMULATOR, NERVE

Model Number	8225103
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.
Event or Problem Description
It was reported that there was a problem with the stimulating probe.Requests for additional information have been made with no additional information provided at this time.There was no patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM® PROBE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6472899
• Report Number: 1045254-2017-00112
• Device Sequence Number: 371604
• Product Code: ETN
• UDI-Device Identifier: 20681490176709
• UDI-Public: 20681490176709
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K934426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2024
• Device Model Number: 8225103
• Device Catalogue Number: 8225103
• Device Lot Number: 0211755265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1