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

Model Number S7

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The reported event could not be duplicated by medtronic personnel.

Event Description

A medtronic representative reported that during a functional endoscopic sinus surgery (fess) the navigation system became unresponsive to any clicks or commands after the patient was successfully registered.The site was able to exit and shut down the system and reboot to resolve the issue.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

The system logs were reviewed but provided no additional insight regarding the cause of the reported complaint.Two core.Reconstruct files were generated in one of the sessions, but one was truncated and the back trace of the other could not be obtained.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

• 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: peter verhey ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6143160
• MDR Text Key: 61403485
• Report Number: 1723170-2016-05333
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2016
• 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