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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE
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MEDTRONIC XOMED INC. NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE Back to Search Results
Model Number 8229738
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/09/2019
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 health care provider reported via manufacturer representative that there was a hole in cuff which was noticed during the procedure.The tube was replaced with a new one to complete the procedure.There was no patient injury.
 
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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 Key9081431
Report Number1045254-2019-00462
Device Sequence Number2656717
Product Code ETN
UDI-Device Identifier00643169782655
UDI-Public00643169782655
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K112686
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/18/2019
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 Date01/27/2023
Device Model Number8229738
Device Catalogue Number8229738
Device Lot Number0217015180
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/28/2019
Initial Report FDA Received Date09/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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