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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
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 that the device needed a repair.There was no known patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow up, it was confirmed that the device stopped working prior to use and there was no patient or staff 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: 8529177
• Report Number: 1045254-2019-00201
• Device Sequence Number: 1920717
• Product Code: GWF
• UDI-Device Identifier: 00613994911025
• UDI-Public: 00613994911025
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K061639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: MDP201
• Device Catalogue Number: MDP201
• Device Lot Number: 208354087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1