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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)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found battery cpu board defective, no date and time.Software version (b)(4) is present.Cpu board has been replaced.The latest available software version (b)(4) has been installed.The device has been successfully tested according to its manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A healthcare provider (hcp) reported that the device was not working.There was no patient impact.
 
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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 Key9376118
Report Number1045254-2019-00630
Device Sequence Number11277869
Product Code ETN
UDI-Device Identifier00613994529060
UDI-Public00613994529060
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
Report Date (Section B) 11/26/2019
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 Model Number8253202
Device Catalogue Number8253202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2019
Initial Report FDA Received Date11/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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