MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735665

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the camera cart was not communicating.The system worked fine during a case in the morning.The manufacturer representative (mr) was using the system for another case and he powered on the navigation device and loaded up exams.He exited out of the software by going to the main login screen on the top right and selecting shutdown, the main cart monitor displayed no video detected, the blue light stayed powered on and he didn't hear the computer fan running, the main cart never shutdown fully.The camera cart monitor and camera cart power were still on but searching for connection at that point.The mr restarted everything, and the main cart monitor still showed no video, but the blue power light was on, the camera cart monitor showed unable to connect.He restarted again, and the main cart monitor came up correctly, but the camera cart connection was never established.The camera cart was displaying this indefinitely.The self-test showed main cart ups and camera cart ups connection was lost.There was no patient present when this issue was identified.

Manufacturer Narrative

A medtronic representative when to the site to test the navigation system.The router was replaced.A full system checkout was completed and the system performed as intended.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM 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
• MDR Report Key: 7781936
• MDR Text Key: 117153708
• Report Number: 1723170-2018-04028
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1