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

Model Number	945EEX901
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 945eex901, serial/lot #: (b)(4)/215046297, udi#: (b)(4) ; product id: 945daq916, serial/lot #: (b)(4)/212935723, udi#: (b)(4).Analysis on serial number #(b)(4) found broken cosmetic nuts.The cosmetic nuts were replaced.The device was repaired, tested, and passed manufacturing specifications.Analysis on serial number #(b)(4) found a loose connector port and a missing cosmetic nut.The cosmetic nut was replaced.The device was repaired, tested, and passed manufacturing specifications.Analysis on the amplifier found a defective front-end board and middle board.The affected parts were replaced.The device was repaired, tested, and passed manufacturing specifications.(b)(4).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 amplifier and stimulators were not working.There was no known patient impact reported.

• Brand Name: NIM-ECLIPSE® STIMULATOR EXTENDER
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8061505
• Report Number: 1045254-2018-00589
• Device Sequence Number: 13997988
• Product Code: GWF
• UDI-Device Identifier: 00643169071865
• UDI-Public: 00643169071865
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 11/12/2018

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: 945EEX901
• Device Catalogue Number: 945EEX901
• Device Lot Number: 213083863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1