MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734060
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6) no parts have returned to the manufacturer for analysis.  h6) multiple annex a codes were applied to capture this event.A110201 captures the system not initiating properly and showing a no signal message while a0902 captures the no visual display on the cpu laptop.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that during the pre-op [phase], the medtronic navigation system did not [initiate] upon activating the "on" switch.The display showed a no signal message and there was no visual on the central processing unit (cpu) laptop.There was troubleshooting present, the system was rebooted twice and the system then [initiated] properly. there was no patient involvement or presence.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20291688
• Report Number: 1723170-2024-02810
• Device Sequence Number: 18174431
• Product Code: HAW
• UDI-Device Identifier: 00643169486645
• UDI-Public: 00643169486645
• Combination Product (Y/N): N
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown