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

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

Missing udi number. A medtronic representative went to the site to test the equipment. Testing revealed that the system was functioning as intended. The system passed the system checkout and was found to be fully functional.

Event Description

Medtronic received information regarding a navigation system during a cranial resection. It was reported that the site registered their patient and verified at known anatomical points and made their burr hole. After this, the surgeon wanted to change his entry point so he put the passive planar on the new entry point and the stealth coordinator at the site tried to make a new entry point but the screen was "flickering around". The surgeon put the passive planar blunt (ppb) down and went to the navigation system. When the surgeon went back and navigated the ppb again, the system was displaying 5cm into the brain. The site switched to the navigus probe and it also showed 5cm deep. The surgery was aborted and rescheduled for next time.

Manufacturer Narrative

Additional information: udi and probable cause of issue. Upon communication with on-site representative, it is possible the cause of the issue is related to unintended movement of the reference frame.

• 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: jack edell ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7710704
• MDR Text Key: 114722872
• Report Number: 1723170-2018-03631
• 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: 08/15/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/23/2018
• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse