MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problems Failure to Run on Battery (1466); Environmental Compatibility Problem (2929); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

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

Event Date 07/05/2019

Event Type  malfunction  

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 navigation system functioned as designed. The system then passed the system checkout and was found to be fully functional. The logs for the navigation system were reviewed by medtronic personnel. It was reported that the logs showed no indication of a software anomaly occurring. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection procedure. It was reported that the camera cart shut down. It was on initially when patient exams were loaded, but when the representative returned to the room later to begin the case, the camera cart was off. This issue was resolved with a reboot and did not reoccur. There was less than an hour delay to the procedure and no impact on the patient's outcome. Additionally, during this case, the system lost audio. This was also resolved with a reboot of the system. Additionally, during this case, both the passive planar probe (in use) and the touch-n-go probe (red, not in field) were visible in the bottom right corner of the navigation screen. Medtronic received information that the camera cart was plugged into a known operational outlet when the reported issue occurred.

Manufacturer Narrative

Software analysis of returned files was performed with respect to all reported issues. With respect to the two instruments being visible issue, the software evaluation found that a probable cause was unable to be determined. The software appeared to be working as designed. With respect to the camera cart shutdown issue, the software evaluation also found that a probable cause was unable to be determined and that the cause was suspected to be a hardware issue. With respect to the no audio issue, software analysis was initiated to determine the probable cause of the issue through known anomaly determination. Analysis found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database. If information is provided in the future, a supplemental report will be issued.

• Brand Name: S8 PREMIUM STEALTHSTATION NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8845417
• MDR Text Key: 152770414
• Report Number: 1723170-2019-04311
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• 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: 10/04/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• 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: 09/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse