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

Model Number	EEX901
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 does not recognize the amplifier, it cannot monitor.There was no patient impact.
Additional Manufacturer Narrative
Analysis found failure a/i pcb.The functional test result are out of spec.There is a pcb failure, therefore the customer's complaint can be confirmed.The top decal is worn.The pcb has been replaced.The device has been tested successfully according to its manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• 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: 9296375
• Report Number: 1045254-2019-00569
• Device Sequence Number: 16295494
• Product Code: GWF
• UDI-Device Identifier: 00613994910998
• UDI-Public: 00613994910998
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K061639
• 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): 12/19/2019

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: EEX901
• Device Catalogue Number: EEX901
• Device Lot Number: 207835611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1