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

Model Number	8253200
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 patient interface came in with missing spare fuses.The reported issue could not be duplicated.As a precaution, the p/i board was replaced.The cable failed triboelectric immunity test and was replaced.The spare fuses were also replaced.The patient interface was successfully tested to manufacturing 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 2 of 2 (patient interface).

• Brand Name: NIM® 3.0 INTERFACE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7266040
• Report Number: 1045254-2018-00052
• Device Sequence Number: 19288432
• Product Code: ETN
• UDI-Device Identifier: 00643169782501
• UDI-Public: 00643169782501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• 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 Expiration Date: 11/20/2013
• Device Model Number: 8253200
• Device Catalogue Number: 8253200
• Device Lot Number: 206555444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1