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

Model Number	8225490
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: 8229708, udi#: (b)(4) and 510k: k112686.No product analysis.The reported products are being shipped from (b)(6) to the us facility.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The site physician (unknown) reported a fiber that was thought to be a nerve was stimulated, but there was no response.No patient impact or injury reported.The procedure was completed using the emg tube and probe.
Additional Manufacturer Narrative
Analysis of one opened sample product number 8225490 from lot number [no information], has been completed.Evaluation indicated 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 stimulating plug / wire to tip showed continuity with a reading of 0.3 ohms.The probe was plugged into a nim system using 1.0 ma stimulating current and 100uv threshold; when stimulating, the system returned 1.02 ma and a waveform / tone over 300uv.There was no evidence of improper manufacturing, no malfunction found and no out of specification condition identified as it relates to the complaint.Analysis of one opened sample product number 8229708 from lot number 0212919339, has been completed.Evaluation indicated no damage or anomalies in the construction of the device that would have resulted in the reported event.Electrically, the resistance of the electrodes from end to end shall be less than 200 ohms and the actual measurements were; red 10 ohms, red [w/white band] 14 ohms, blue 13 ohms, and blue [w/white band] 9 ohms.There were no shorts between circuits or intermittent behavior while manipulating the circuits.When viewed under magnification, there were no cracks in the electrode contacts.The red / white and green end to end ohms resistance shall be less than 2.5 ohms; the actual measurements were 2.0 ohms and 1.9 ohms respectively, which is in specification.There was no fault found, no evidence of improper manufacturing and 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.

• 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: 7366739
• Report Number: 1045254-2018-00125
• Device Sequence Number: 1950248
• Product Code: ETN
• UDI-Device Identifier: 20613994430209
• UDI-Public: 20613994430209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K024316
• 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): 04/27/2018

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 Model Number: 8225490
• Device Catalogue Number: 8225490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1