MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC WRKSTN, 9732585, STLTHSTN INAV II; INSTRUMENT, STEREOTAXIC

Model Number	9732585
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that there was a malfunction with the navigation camera.The malfunction was described as "field of view corrupted got smaller.¿ the problem was that in order for the camera to ¿¿see¿¿ the tools, it needed to be placed very close to the tools.The camera had to be placed less than 50 cm from the probe or the frame.One would not have been able to perform a navigation case with this issue.It was noted that the camera was unusable.There was no patient present as this issue occurred in a demo setup of the system.

• Brand Name: WRKSTN, 9732585, STLTHSTN INAV II
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8136143
• Report Number: 1723170-2018-06082
• Device Sequence Number: 16548327
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: 9732585
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1