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

Model Number	DAQ916
Medical Device Problem Codes	Circuit Failure (1089); False Negative Result (1225); Device Stops Intermittently (1599); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.The evaluation is not yet complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported an intermittent issue with the module and some of the ports were not detecting.The nerve location was known, but the device was not detecting it.The customer was able to confirm the issue by replacing the module.Once replaced, the system worked fine.There was no patient injury.
Additional Manufacturer Narrative
Incoming inspection found electrode 7 and 8 open.The unit will be sent for further repairs and analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported an "intimate issue" (not working) with the daq pre-amplifier pre-operatively.There was no impact to the patient.

• Brand Name: NIM-ECLIPSE® PREAMPLIFIER
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7413277
• Report Number: 1045254-2018-00157
• Device Sequence Number: 16418213
• Product Code: GWF
• UDI-Device Identifier: 00613994910950
• UDI-Public: 00613994910950
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: DAQ916
• Device Catalogue Number: DAQ916
• Device Lot Number: 208619641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1