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); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

A medtronic representative reported that, while in a spine based procedure, an error appeared on the application software.It was reported that the navigation system displayed that the task flow file could not be found for the procedure.It was reported that the issue occurred navigation system shut down when an ethernet cable was attached to the navigation system.The issue was reported to have occurred prior to attaching an imaging system to the navigation system for the procedure.Restarting the navigation system was reported to have restored functionality.When in a standard surgeon profile, it was noted that the error message would reappear.A new procedure was created under a separate surgeon profile and the site was able to continue with the procedure.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Additional information: a medtronic representative reported that the procedure was delayed between five to ten minutes due to the reported issue.Patient demographics provided.

Manufacturer Narrative

Correction: event date updated to proper value.A software investigation of the logs show a total of three sessions, one of which transitions from verify instruments to acquire imaging system scans then logging terminates.The other sessions exit normally.No additional information was found within the logs.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.

Manufacturer Narrative

Correction: device manufacture date updated to proper value.

• 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7218722
• MDR Text Key: 98281730
• Report Number: 1723170-2018-00402
• 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,Followup,Followup
• Report Date: 07/25/2018

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: 9733856
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 01/26/2018; 05/14/2018; 07/12/2018
• Supplement Dates FDA Received: 02/12/2018; 06/11/2018; 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2011
• 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
• Patient Age: 59 YR
• Patient Weight: 76