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

Model Number S7

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.The representative reported that the computer for the navigation system was replaced, but the reported issue was not resolved.It was reported that following replacement, a ¿no signal¿ message appeared on the navigation system when exiting the administrative portion of the software.It was noted that the navigation system was unresponsive for five minutes during this phase and a hard restart of the system was performed.A second medtronic representative reported that the video splitter was bypassed without resolution.It was reported that the navigation system would function as designed prior to the fan cover being placed on the navigation system near the computer.It was reported that the axiem communication cable was disconnected, the fan cover was placed back on and the reported issue of ¿no signal¿ messages being displayed could not be replicated after a restart of the system.The representative reported that the axiem communication cable was replaced to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The computer for the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The communication cable was returned to the manufacturer for analysis.The cable was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Event Description

A medtronic representative reported that while outside of procedure, when entering admin after powering on the navigation system, the screen displayed black and became unresponsive.Representative hard shutdown the system and when booted back on, the camera lights were on but the computer fan was cycling and the screen displayed blank.After performing a hard shutdown again the system functioned normally.Representative was able to progress to admin desktop.There was no patient present at the time of the issue.

• 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: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6962328
• MDR Text Key: 90646671
• Report Number: 1723170-2017-04233
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• 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: 09/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2010
• 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