MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTH INAV PORTABLE SYSTEM; 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	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The location where the reported event was not provided.The camera was returned to the manufacturer for analysis.However, the camera was returned after having been completely disassembled.As a result it was not possible to perform a functional testing and cause of the reported issue.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 the camera does not work.There was no patient present when this issue was observed.
Additional Manufacturer Narrative
Correction: updated with missed detail e1 updated with facility information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the hospital sent the camera in a disassembled state, which is how it was received for analysis.

• Brand Name: STEALTH INAV PORTABLE SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8449227
• Report Number: 1723170-2019-01326
• Device Sequence Number: 3056858
• Product Code: HAW
• UDI-Device Identifier: 00613994110831
• UDI-Public: 00613994110831
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 9732585
• Device Catalogue Number: 9732585
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1