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

Model Number	8253410
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis received the device in good cosmetic condition.There was no fault with the device.The device was tested and passed manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via manufacturer representative that the interface would not recognize the electrodes.There was no known patient impact reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from health care professional (hcp) reported via manufacturer representative that the interface would not recognize the electrodes during testing before the procedure.There were no back-up devices used and there was no delay to the procedure.There was no patient involvement.

• Brand Name: NIM-NEURO® PATIENT INTERFACE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8119418
• Report Number: 1045254-2018-00671
• Device Sequence Number: 13519149
• Product Code: ETN
• UDI-Device Identifier: 00643169283299
• UDI-Public: 00643169283299
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 8253410
• Device Catalogue Number: 8253410
• Device Lot Number: 211436146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1