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

Model Number	8253001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 8253200, serial/lot #: (b)(4), udi#: (b)(4).The product analysis result indicates that there was no fault found in the mainframe.The patient interface came in with channel failure due to a/i pcb failure.There was also loose clips.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by a health care professional that the device was non specific broken.There was no known impact or consequence to patient.

• 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 Key: 10660848
• Report Number: 1045254-2020-00465
• Device Sequence Number: 4044303
• Product Code: ETN
• UDI-Device Identifier: 00643169547049
• UDI-Public: 00643169547049
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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 Number: 8253001
• Device Catalogue Number: 8253001
• Device Lot Number: 211862732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1