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

Model Number 9735665

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Other relevant device(s) are: product id: 9735795r, serial/lot #: (b)(4).The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the monitor was replaced.The monitor was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The reported problem could not be duplicated.They ran the monitor for multiple days and the monitor remained working during testing.Touch screen and audio functioned normally without failure.When they plugged the monitor in it did show horizontal flickering at the splash screen.An electrical failure was observed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that the camera cart screen was not functioning.The main cart worked without issue and the camera was working too.The screen was flickering on the monitor when power up.No patient was present at the time of the event.Additional information was received stating that the monitor was not able to display data.

• Brand Name: S8 PREMIUM
• 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: 9622409
• MDR Text Key: 183954642
• Report Number: 1723170-2020-00222
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• 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