MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-NEURO® 3.0 MAINFRAME; STIMULATOR, NERVE

Model Number	8253402
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
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.Other relevant device(s) are: product id: 8253410, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The health care provider reported that the mainframe and interface had a loud noise during the procedure.The initial check of the machine, the ticks were on and off.There was no delay in the procedure.There was no patient impact.
Additional Manufacturer Narrative
Analysis of the mainframe found that the reported fault could not be duplicated.Pm to be carried out as per manufacturer's specifications.Electrical test to be performed.The unit was cleaned and sanitized.The unit tested to specifications as per service repair instructions and electrically tested to standard.All test passed.While, analysis of the interface found that there was no fault with the unit.The unit was cleaned, sanitized and tested to specifications as per service repair instructions.All tests passed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM-NEURO® 3.0 MAINFRAME
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8413110
• Report Number: 1045254-2019-00132
• Device Sequence Number: 19393614
• Product Code: ETN
• UDI-Device Identifier: 00643169230378
• UDI-Public: 00643169230378
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• 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): 04/22/2019

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 Number: 8253402
• Device Catalogue Number: 8253402
• Device Lot Number: 209587644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1