MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7 STEALTHSTATION NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the computer of the navigation system was replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.The computer for the navigation system was returned to the manufacturer for evaluation.However, results are not available at the time of filing.Other relevant device(s) are: product id: 9734477, serial/lot #: (b)(4), ubd: 31-jan-2017.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that while loading exams, both the monitors went black.The site also reported green flickering lines at the top of the monitor.The site used a different navigation system for an upcoming case.There was no patient present when this issue was discovered.

Manufacturer Narrative

The computer was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S7 STEALTHSTATION NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9953261
• MDR Text Key: 187405776
• Report Number: 1723170-2020-01209
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2012
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1