MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9735670
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the site was not able to register.During a catheter placement procedure the surgeon was unable to verify the tracer pointer or start a trace registration by holding the probe on the skin.The surgeon ended up aborting the use of navigation after trying a different tracer pointer and non-invasive patient tracker (nipt).A manufacturer representative (rep) was on site and replicated the issue.Technical services (ts) requested that the rep check the footswitch behavior in the software and discovered it was set to registration with footswitch, not stationary probe.Ts also informed the rep that the em cranial tracer pointer is an instrument that does not need to be verified in the software.This information will be provided to the site.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue.Software functioning as designed - user error.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9271160
• Report Number: 1723170-2019-05447
• Device Sequence Number: 1646057
• Product Code: HAW
• UDI-Device Identifier: 00643169722194
• UDI-Public: 00643169722194
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 9735670
• Device Catalogue Number: 9735670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 88