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

Model Number	8225101
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found 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 was within 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) and found that there was no malfunction found as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via distributer that the probe was not transmitting stimulation during the procedure.Another probe was used and worked normally.There was no patient impact.
Additional Manufacturer Narrative
Additional product returned which may have actually been the complaint sample.Fdr is being reported again due to system error.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 0.3 ohms 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.

• 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: 8086332
• Report Number: 1045254-2018-00609
• Device Sequence Number: 2324895
• Product Code: ETN
• UDI-Device Identifier: 20681490176686
• UDI-Public: 20681490176686
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 11/06/2024
• Device Model Number: 8225101
• Device Catalogue Number: 8225101
• Device Lot Number: 0212274773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1