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

Model Number	8229706
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A healthcare professional (hcp) reported that during a procedure for thyroidectomy surgery, the cuff was not broken, but it will leak during procedure.There was no delay in the procedure.The procedure was completed with the reported product(s).The patient was alive - no injury.On follow-up, additional information was received confirmed that the tube was patency prior to intubation the patient.15cc of air was used to inflate the cuff.The patient was intubated 40 minutes after surgery.The airway had already been established when the leak was discovered.Due to the leak, the patient did not required reintubation but need to re-inflate the cuff.It was also reported that it was the initial use of the tube.
Additional Manufacturer Narrative
H3: analysis found that visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.The cuff was deflated when received.Functionally, 20cc of air was injected into the cuff and pressure was applied to the cuff for 1 minute with no signs of leakage; 20cc were removed.This was repeated 5 times, detaching and reattaching the syringe from the inflation assembly each time with no issues or leakage.There was no evidence to support improper manufacturing and therefore has been ruled out as a likely cause.The cuff is inflated and left inflated in multiple manufacturing steps; the cuff is leak tested with a fixture while submerged in water to detect smaller leaks (looking for bubbles); the cuff is dry tested using a fixture.In the returned condition, there was no out of specification condition that is likely related to the complaint.H6: fdm 4114 and fdr 3221 are no longer applicable.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 - TRIVANTAGE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10710700
• Report Number: 1045254-2020-00480
• Device Sequence Number: 16958710
• Product Code: ETN
• UDI-Device Identifier: 00643169782587
• UDI-Public: 00643169782587
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: 03/29/2024
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0219809605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1