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

Model Number	8225101
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
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 distributor that during a procedure for thyroidectomy, the doctor found that the probe's detection was not sensitive, sometimes there was a response and sometimes there was no response.After several attempt, it still didn't improve.Finally, the doctor changed to a new one to complete the surgery; there was an 8 minutes delay in the procedure; there was no intervention/planned performed; the procedure was successfully completed using back-up products.There was no patient impact.
Additional Manufacturer Narrative
H3: analysis found no damage or anomalies in the construction of the device.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; the actual measurement was 0.3 ohm which is in specification.There was no intermittent behavior while manipulating the tip, connector, or 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.H6: fdm 4114, fdr 3221 and fdc 67 no longer apply.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received mentioned that the stim return was not 0 and there was no visual or audible indicator.

• 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: 9749555
• Report Number: 1045254-2020-00107
• Device Sequence Number: 14160598
• 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
• Report Date (Section B): 04/08/2020

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 Model Number: 8225101
• Device Catalogue Number: 8225101
• Device Lot Number: 0217329506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1