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

Model Number	945ECLC
Medical Device Problem Codes	Intermittent Continuity (1121); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 healthcare professional (hcp) reported that the controller was intermittently not working and shuts down in the middle of cases.There was no patient impact.
Additional Manufacturer Narrative
Analysis found that the customer's complaint could not be duplicated.The power supply was loose due to incorrect screws.The screws were replaced and tightened.The device was cleaned, tested and passed according to manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NIM-ECLIPSE® CONTROLLER
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7741995
• Report Number: 1045254-2018-00345
• Device Sequence Number: 16663007
• Product Code: GWF
• UDI-Device Identifier: 00643169071872
• UDI-Public: 00643169071872
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K050798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2018

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: 945ECLC
• Device Catalogue Number: 945ECLC
• Device Lot Number: 212558426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/19/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1