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

Model Number	8225101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation was performed as the device has not been returned at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A customer reported via a manufacturer representative that current didn¿t come out from the probe.The surgeon used another new one instead.No patient impact was reported.
Additional Manufacturer Narrative
Visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The tip fit securely in the handle.The resistance of the assembly shall measure less than 0.3ohms while using a 4-wire ohm meter (a 2-wire meter was used in lieu of the 4 wire); the actual measurement was 0.2 ohm which is in specification.There was no intermittent behavior while manipulating the tip, connector, and wire.The probe was plugged into a nim system (with a patient simulator) using 1.0 ma stimulating current and 100uv threshold; when stimulating, the system consistently returned 1.02 ma and a waveform / event tone over 300uv.If information is provided in the future, a supplemental report will be issued.
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: 7718593
• Report Number: 1045254-2018-00318
• Device Sequence Number: 16326694
• Product Code: ETN
• UDI-Device Identifier: 00681490176682
• UDI-Public: 00681490176682
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K934426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 03/04/2026
• Device Model Number: 8225101
• Device Catalogue Number: 8225101
• Device Lot Number: 0215026084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 09/05/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1