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

Model Number	DAQ916
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device was received with chipped cover, rubber bumpers missing and no output.Chipped cover parts have been replaced.The device has been successfully tested according to its manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that the device was not working.There was no patient impact.
Additional Manufacturer Narrative
Initial aware date should be 2019-09-06, an email attachment (not in english) dated (b)(4).Was translated on (b)(4).The translation states that on (b)(4).There was a device allegation of not working.If information is provided in the future, a supplemental report will be issued.

• 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: 9166096
• Report Number: 1045254-2019-00496
• Device Sequence Number: 3643564
• Product Code: GWF
• UDI-Device Identifier: 00613994910950
• UDI-Public: 00613994910950
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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: DAQ916
• Device Catalogue Number: DAQ916
• Device Lot Number: 206883825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1