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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2018
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 professional (hcp) reported that the controller was having issues with acquiring motor evoked potentials (mep).No response was achieved after having a voltage up until 700 volts.The patient would sometimes react to the stimulus and sometimes there is no reaction.No back-up device was used and there were no issues during the procedure but mep was not run at the time.There was no known patient impact reported.
Additional Manufacturer Narrative
Analysis found no fault with the device.The complaint could not be duplicated.The device was tested and passed manufacturing s pecifications.The complaint could not still be duplicated in the burn in.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from a health care professional (hcp) reported that the event occurred during the procedure.There was no delay in the procedure as the same device was used.There was no 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: 8204017
• Report Number: 1045254-2018-00751
• Device Sequence Number: 16209329
• Product Code: GWF
• UDI-Device Identifier: 00643169071872
• UDI-Public: 00643169071872
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: 945ECLC
• Device Catalogue Number: 945ECLC
• Device Lot Number: 215044527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1