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

Model Number	8253200RF
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: 8253001rf, serial/lot #: (b)(4), ubd: n/a, udi#: (b)(4), 510k number - k083124.(b)(4) (nim 3.0 patient interface): no product analysis results available.Device evaluation anticipated but not yet begun.(b)(4) (nim 3.0 mainframe): the product analysis indicates that the reported issue could not be duplicated.A 24-hour burn-in testing was performed.There was no fault found with the device.The device tested and passed all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the device was working intermittently.There was no patient impact.
Additional Manufacturer Narrative
The product analysis indicates the patient interface came in with broken cable clip and patient interface pcb failure.The reported issue was confirmed.The p/i pcb board was replaced due to failure.The broken cable clip was also replaced.The patient interface was repaired and successfully tested to specifications.If information is provided in the future, a supplemental report will be issued.

• 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: 7561975
• Report Number: 1045254-2018-00227
• Device Sequence Number: 1277595
• Product Code: ETN
• UDI-Device Identifier: 00643169782501
• UDI-Public: 00643169782501
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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 Number: 8253200RF
• Device Catalogue Number: 8253200RF
• Device Lot Number: 68300600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1