MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION(TM) S7(R); INSTRUMENT, STEREOTAXIC

Model Number	9734048
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: 9733877, serial/lot #: (b)(4).The manufacturer representative went to the site to test the navigation system.The system was performing as intended and no hardware parts were replaced.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.The manufacture date was not available at the time of the event.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the application software would not boot on the planning system.There was no patient present when this issue was identified.No additional information was provided.Additional information was received.It was reported that the correct event date is (b)(6) 2020, not (b)(6) 2020.The event description has been updated to reflect this.

• Brand Name: STEALTHSTATION(TM) S7(R)
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11589281
• Report Number: 1723170-2021-00825
• Device Sequence Number: 17217507
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Report Date (Section B): 03/30/2021

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: 9734048
• Device Catalogue Number: 9734048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1