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

Model Number 9733856

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 9734477, serial/lot #: unknown.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 the cranial software was becoming unresponsive.A demo model was able to register, but then the system became unresponsive and needed to be rebooted.The manufacturing representative went back into the software and the system then became unresponsive in planning.After another reboot, the manufacturing representative would go back into the software and it started kicking him out of the software, but wouldn't allow him to get fully to the splash screen.This happened two more times.The manufacturing representative went into admin and uninstalled the cranial software.After the reboot he attempted to re-install the software but the system stated the install failed.Then there was a message stating kernel errors.There was no patient involved.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The computer was replaced.The system then passed a system checkout.The computer with lot number 1823999 was returned to medtronic.The computer is under analysis at the time of filing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The returned computer was analyzed.Analysis revealed that the computer booted normally to the application screen.Software installed without issue.The computer started and ran normally.No unresponsiveness was observed in navigation mode.No failures were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7
• 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: 9363231
• MDR Text Key: 178539246
• Report Number: 1723170-2019-05727
• 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,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2013
• 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