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

Model Number S7

Device Problems No Display/Image (1183); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. A medtronic representative inspected the navigation system onsite and confirmed the issue. The representative attempted to perform a system checkout by uninstalling/reinstalling the software, however the computer was crashing. The system computer was replaced and the issue was resolved. A full navigation system check-out was completed following part replacement and all tests passed. Full system functionality was confirmed and the system was returned to service. No parts have returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of a procedure while pulling logs from cranial, the top 1/4 of the monitor on the navigation system would begin flickering between a block screen and the software. The remaining 3/4 remained completely black. The representative rebooted the system and entered cranial again and the system appeared to act normal until attempting to pull the logs again, the same issue occurred. To trouble shoot, the representative booted into spine and after approximately 3 minutes in spine, the monitor would display 'no input detected' and would not display an image at all with cord reseats. There was no patient present when this issue was observed. No additional information was provided.

• 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: stephanie riley ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7118582
• MDR Text Key: 94973045
• Report Number: 1723170-2017-05153
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse