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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that no deviations or fault found.The device has been received in good condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that the interface was non-specific damaged.There was no patient impact.

• 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: 10400251
• Report Number: 1045254-2020-00367
• Device Sequence Number: 2854331
• Product Code: ETN
• UDI-Device Identifier: 00643169283299
• UDI-Public: 00643169283299
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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: 8253410
• Device Catalogue Number: 8253410
• Device Lot Number: 211488061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1