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

Catalog Number 9735669

Device Problems No Display/Image (1183); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. A medtronic representative went to site to test the equipment. Representative confirmed that the leds were not lighting up on uninterruptible power supply (ups) despite being properly connected on both ends. Representative reported that the reported issue was intermittent. A uninterruptible power supply (ups) was replaced and the issue resolved. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect uninterruptible power supply (ups) has been received by the manufacturer for evaluation. The returned uninterruptible power supply (ups) was tested and found to power on all ports when power button was pressed and all outputs measured expected voltages. Fets measure as designed. When attempting to check charging circuit, battery was attached and when power was applied, the red error light would flash. The issue could be reproduced with two other different known good batteries.

Event Description

A medtronic representative on behalf of site reported that while outside of procedure, when setting up for case after a successful case with the navigation, the monitor of the system displayed black. Rebooting the system multiple times did not resolve the issue as the system did not display medtronic logo. Site verified that all cables were seated and attempted to turn on the monitor with the buttons on the bottom right of the screen. No additional information was provided. There was no patient present at the time of the issue.

Manufacturer Narrative

The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: STEALTHSTATION S8 EM ENT 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 ; 7208902515
• MDR Report Key: 7289122
• MDR Text Key: 100769192
• Report Number: 1723170-2018-00813
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse