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

Model Number	945DAQ916
Medical Device Problem Codes	Use of Device Problem (1670); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the device came in with excessive blood around the seals which leaked onto the top board microprocessor which caused the failure.There were components failure and microprocessor liquid damage.The device was cleaned, replaced top board, applied rtv to connectors, applied tape, replaced 2 torn gaskets, placed into burn-in for 8 hours to check for any heat related failures and tested in accordance with manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that the device failed the impedance test and was not working properly.There was no patient impact reported.

• 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: 7962826
• Report Number: 1045254-2018-00504
• Device Sequence Number: 11197408
• Product Code: GWF
• UDI-Device Identifier: 00643169071933
• UDI-Public: 00643169071933
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/12/2018

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: 945DAQ916
• Device Catalogue Number: 945DAQ916
• Device Lot Number: 205892585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1