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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 3.0 MAINFRAME; STIMULATOR, NERVE
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MEDTRONIC XOMED INC. NIM® 3.0 MAINFRAME; STIMULATOR, NERVE Back to Search Results
Model Number 8253001LO
Medical Device Problem Code Failure to Sense (1559)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/04/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis of the device found no fault.The item was tested and passed all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A manufacturer representative (rep) reported that the stimulation probe function was not working.There was no audible feedback.It was reported that the event occurred intra-operative and no patient impact occurred.
 
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Brand Name
NIM® 3.0 MAINFRAME
Common Device Name
STIMULATOR, NERVE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key7473722
Report Number1045254-2018-00180
Device Sequence Number114123
Product Code ETN
UDI-Device Identifier00643169782488
UDI-Public00643169782488
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K083124
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 04/30/2018
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 Number8253001LO
Device Catalogue Number8253001LO
Device Lot Number207749067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2018
Initial Report FDA Received Date04/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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