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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 8253001RF
Medical Device Problem Code Device Stops Intermittently (1599)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/18/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product analysis indicates the mainframe came in with a white line across the left side of the touchscreen display upon boot-up.The reported issue could not be verified.The lcd display was replaced.The mainframe was placed into burn-in for four hours.The device was tested and passed to specifications.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The customer reported that the nim system was intermittently not working.The case was completed with a backup device.There was no patient impact.This is regulatory report 1 of 2 (nim mainframe).
 
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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 Key7266026
Report Number1045254-2018-00051
Device Sequence Number1827317
Product Code ETN
UDI-Device Identifier00643169871014
UDI-Public00643169871014
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K083124
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 02/13/2018
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 Number8253001RF
Device Catalogue Number8253001RF
Device Lot Number211400155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/18/2018
Initial Report FDA Received Date02/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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