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

Model Number 9735665

Device Problems Display or Visual Feedback Problem (1184); Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment. Testing revealed that the monitor was working well. It was crossed checked with another monitor from the camera cart and both worked well. The control key on the main monitor was unlocked. It was noted that since the touch key on the monitor was unlocked, the source selection for the display was able to be changed. The representative locked it. It was suspected that the speaker issue was caused by a software issue. If the user restarted the application, the speaker worked well. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system. It was reported that sometimes the monitor could not display. It was reported that the monitor would turn on and lose functionality sometimes. It was also reported that the speaker was not working. There was no patient present when this issue was identified.

Manufacturer Narrative

A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined. If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM 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: 8586167
• MDR Text Key: 144278484
• Report Number: 1723170-2019-02190
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse