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

Model Number 9735665

Device Problems Application Program Problem (2880); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative (rep) went to the site to test the equipment.The rep uninstalled and reinstalled the application, and the issue was no longer present.It then worked and the rep was able to build registration models and register on the resin head.The navigation 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 device being used for a cranial resection procedure.It was reported that a medtronic representative (rep) was loading exams for the case and the registration model would not build.On the registration task the model screen was just black.When the rep clicked the build model button, nothing would happen and the task would not appear.There were no error messages displayed on the screen.The site had three exams and all of them would not build a registration model.A different exam was re-pushed but the site was still unable to build.The system had been rebooted as well.The site opted to abort use of the navigation system for the case.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.Further troubleshooting was performed for the reported issue.The site went into another patient and it was able to build the previously built registration model, but when clicking edit model it would do the same behavior where it would not open the task.They went into build a model in the plan task and when attempting to build a tumor model, it would throw an error.This was also happening on the demo exams.The rep tried to click them several times and out of many attempts, the build model was able to open one time.The rep went to delete patients off the system, but now after clicking confirm the system would not do anything and the patient exam would stay.Technical services (ts) recommended uninstalling and reinstalling the application to refresh the database.After uninstalling and reinstalling the application, the issue was no longer present.Software engineering reviewed the information and noted that this issue is consistent with a known software issue.

Manufacturer Narrative

Other relevant device(s) are: product id: 9735737, serial/lot #: unknown.Device evaluation: a software analysis was completed.It was found that the reported issue was related to a known software anomaly.This anomaly is tracked through a software anomaly tracking database and references to this case have been added.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PLUS 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: 8669183
• MDR Text Key: 149382049
• Report Number: 1723170-2019-02948
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2018
• 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
• Patient Age: 56 YR
• Patient Weight: 88