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

Model Number S7

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection procedure. The issue occurred intraoperatively during the navigate task and delayed surgery by 10 minutes. It was reported that the surgeon was unable to put a projection on the passive planar probe in navigation. The surgeon rebooted the system three times and had to re-register all three times with no resolution. The surgeon went to ¿checkpoints¿, then closed the checkpoints, and the select projection button was once again available. The procedure was completed with the use of navigation. No known impact on patient outcome.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated and the issue has not occurred again. The system then passed the system checkout and was found to be fully functional.

• 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7664001
• MDR Text Key: 113240602
• Report Number: 1723170-2018-03143
• 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

• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/05/2018
• 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: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse