MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿; STIMULATOR, NERVE

Model Number	8229970
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2019
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 provider (hcp) reported that via a distributor that during a thyroidectomy procedure, the tube was positioned at the patient and suddenly the electrode part detached and fell.They continued using the tube without the electrode and using cheang¿s method to do monitoring.There was no patient impact or injury.
Additional Manufacturer Narrative
Product analysis: visually, the electrode circuits were separated at the flex circuit which would have resulted in the reported event.The separation showed no elongation of the surrounding material to indicate it was pulled apart; there was no degradation of the surround area to indicate a raw material issue; the separation edge was smooth and linear which is consistent with being cut.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8714466
• Report Number: 1045254-2019-00299
• Device Sequence Number: 13918328
• Product Code: ETN
• UDI-Device Identifier: 00643169358805
• UDI-Public: 00643169358805
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K925640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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: 06/20/2022
• Device Model Number: 8229970
• Device Catalogue Number: 8229970
• Device Lot Number: 0215705703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 03/06/2020
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 10/08/2019; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1