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

Model Number	945EEX901
Medical Device Problem Codes	Break (1069); Intermittent Continuity (1121); Device Sensing Problem (2917); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2019
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 reported that the device get intermittent mild noise again and the mep (motor evoked potentials) function does not seem to work all the time.Switched port for mep from the left to right but haven't monitored enough cases needing motors to determine if that is really the problem.At the start of cases, able to elicit meps but at the end nothing was recorded.Now, the hcp was hearing something inside the box rattling; something was broken.The problem has occurred intermittently.There was no impact on patient or surgeon.Additional information received stated that the port was changed.

• 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: 9005697
• Report Number: 1045254-2019-00443
• Device Sequence Number: 2652616
• Product Code: GWF
• UDI-Device Identifier: 00643169071865
• UDI-Public: 00643169071865
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 945EEX901
• Device Catalogue Number: 945EEX901
• Device Lot Number: 215124170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1