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

Model Number 9733856

Device Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) - a manufacturer rep went to the site to test the system.The system passed the system checkout.Pli30 - software analysis was performed and software logs were reviewed.Found the core file on the date of issue with signal 6 abort.There was an error connecting to the database.The issue was confirmed and is being tracked.Continuation of concomitant products: information references the main component of the system.Other relevant device(s) are: product id: 9 733686, serial/lot #: software version: 2.1.0.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that prior to a case, when trying to launch the spine software, the first_run.Py ran and when it completed it told the user to press any key to continue.The user pressed a key and nothing occurred, the screen remained black.Technical services (ts) had the site do a soft reboot and re-launch the spine application.The first_run.Py ran again and when it completed it told the user that the installation failed and to press any key to continue.Again when a key was pressed nothing happened, they were unable to get the spine application to launch.The site cancelled the case.The computer had previously been replaced and this issue occurred when the spine tools cd was loaded but the installation was not completed.There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION S7
• Type of Device: 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12476442
• MDR Text Key: 271587842
• Report Number: 1723170-2021-02286
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1