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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 8253001
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/11/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found no fault with the device.The customer's complaint could not be duplicated.The mainframe was cleaned and tested in accordance to manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A health care provider reported that the mainframe was not working, tried changing out a new interface cable and still had issues.There was no patient impact reported.
 
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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 Key10968102
Report Number1045254-2020-00603
Device Sequence Number16778780
Product Code ETN
UDI-Device Identifier00643169547049
UDI-Public00643169547049
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K083124
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/08/2020
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 Number8253001
Device Catalogue Number8253001
Device Lot Number212374873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/11/2020
Initial Report FDA Received Date12/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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