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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 3.0 MAINFRAME - PULSE; STIMULATOR, NERVE
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MEDTRONIC XOMED INC. NIM® 3.0 MAINFRAME - PULSE; STIMULATOR, NERVE Back to Search Results
Model Number 8253202
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/03/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.  a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A healthcare provider (hcp) reported that a nerve monitoring device was not working properly.There was no patient impact.
 
Additional Manufacturer Narrative
Analysis found that there was no fault in the device.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
NIM® 3.0 MAINFRAME - PULSE
Common Device Name
STIMULATOR, NERVE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key9637401
Report Number1045254-2020-00059
Device Sequence Number3444944
Product Code ETN
UDI-Device Identifier00643169230415
UDI-Public00643169230415
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K083124
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,Followup
Report Date (Section B) 02/19/2020
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 Number8253202
Device Catalogue Number8253202
Device Lot Number210530259
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/06/2020
Supplement Date Received by Manufacturer01/29/2020
Initial Report FDA Received Date01/28/2020
Supplement Report FDA Received Date02/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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