MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-ECLIPSE® MUTE DETECTOR PROBE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	MDP201
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via distributor that the muting probe was not working properly.There was no known patient impact.

• Brand Name: NIM-ECLIPSE® MUTE DETECTOR PROBE
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8041097
• Report Number: 1045254-2018-00565
• Device Sequence Number: 1187938
• Product Code: GWF
• UDI-Device Identifier: 00613994911025
• UDI-Public: 00613994911025
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K061639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: MDP201
• Device Catalogue Number: MDP201
• Device Lot Number: 208113301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1