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

Model Number	945ECLC
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the device had a connection failure due to twisted pins on the stimulator connector.The device was disassembled, cleaned, replaced connector pcba, applied loctite to connectors, reassembled, and placed into the burn-in chamber to check for any heat related failures.The device was removed and tested in accordance with manufacturing specifications.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 was not producing a high stimulus; when both stimulators were plugged in they were getting an electrical stim failure; tried with two other stimulators on the same device and had the same issue.There was no known patient impact.

• 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: 8090442
• Report Number: 1045254-2018-00626
• Device Sequence Number: 1684480
• Product Code: GWF
• UDI-Device Identifier: 00643169071872
• UDI-Public: 00643169071872
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 208362595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1