MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Erratic or Intermittent Display (1182); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.The suspect computer was returned for evaluation, however results are not yet available.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the system was intermittently unresponsive.The issue has been happening in multiple stages of the software.During the call, while in the planning screen and scrolling through slices, the system stopped responding to the user's input, and the keyboard did not respond to any user input including an attempt to soft reboot the system either.Additionally, the mouse was also no longer responsive to the user's input.During troubleshooting, they restarted the system and after restarting, the system stopped responding once again and once it stopped responding, the display began to show artifacts on the screen.After restarting the system one more time, the system started responding.There was no clinical impact or patients present.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the "system freezes up" and the computer required replacement.The computer was replaced and the imaging system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.Analysis found that the initial boot and navigation of applications, memtest86, and phd all passed testing.Seatools long test failed.The short and long test passed after the repair of bad sectors via seatools disc.Analysis found that the reported event was related to a hard drive malfunction.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7609433
• MDR Text Key: 111323033
• Report Number: 1723170-2018-02814
• Device Sequence Number: 1
• Product Code: HAW
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2010
• 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