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

Model Number	8225101
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the returned device indicated that 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.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.There was no out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional reported that they were not getting readings occasionally when wiggling the cable and the second probe would work only when holding the tip at 90 degrees to the simulator.The tip was bent on the second probe.The device was tested with original probe and test probe.The original probe wouldn¿t respond occasionally.The device was tested with an electrode check and all probes tested 0.6 kohms.Went to monitor mode and tested with biomed probe.All for channels on sim one and sim two gave around 150 uv reading on screen.They confirmed the issue was with probe and not the unit.It was noted that there was no patient impact.

• 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: 7787494
• Report Number: 1045254-2018-00377
• Device Sequence Number: 1985592
• Product Code: ETN
• UDI-Device Identifier: 20681490176686
• UDI-Public: 20681490176686
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K934426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: 10/23/2025
• Device Model Number: 8225101
• Device Catalogue Number: 8225101
• Device Lot Number: 0214268022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1