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

Model Number	8225275
Medical Device Problem Codes	Use of Device Problem (1670); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported via a distributor that after intubation during a thyroidectomy procedure, the probe did not function properly.There was electric current but there was no response.The doctor checked all the connections but was not able to resolve the issue.Another probe was used which functioned well.The procedure was completed but delayed for about 5 minutes.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that visually, there was no damage or anomalies in the construction of the device.The tip fit securely in the handle.The resistance of the assembly measurement was 0.2ohms.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 returned 1.02 ma and a waveform / event tone over 300uv.There was no evidence of improper manufacturing and no malfunction found as it relates to the complaint.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: 7953736
• Report Number: 1045254-2018-00485
• Device Sequence Number: 13503607
• Product Code: ETN
• UDI-Device Identifier: 00681490176750
• UDI-Public: 00681490176750
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 03/05/2026
• Device Model Number: 8225275
• Device Catalogue Number: 8225275
• Device Lot Number: 0215041108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1