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

Model Number S7

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site. A medtronic representative went to the site to test the equipment. Testing revealed that system functioned normally. The system then passed the system checkout and was found to be fully functional. Device manufacturing date is unavailable.

Event Description

Medtronic received information regarding a navigation device being used for a catheter-based procedure. It was reported that, intraoperatively during the navigation task, there was an axiem tracking failure. The surgeon registered correctly and navigation was accurate; registration was taken over the whole head as is recommended. The surgeon marked the site for incision and burr hole. After scrubbing, the surgeon used the stylet to navigate; when the surgeon moved the stylet to the entry point at the back of the head, the image went blank. Navigation was accurate at the front of the head and accuracy maintained throughout. Both the tracker and probe remained green and visible. The surgeon stopped and unstopped navigation using the foot pedal and flicked through screens to try different things. Eventually it worked but the surgeon was unsure how. There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

Manufacturer Narrative

Additional information: device manufacture date provided. Correction: product, unique device identification (udi), and related fields 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 ; 7208903200
• MDR Report Key: 7615877
• MDR Text Key: 111560940
• Report Number: 1723170-2018-02858
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/19/2018
• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse