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

Model Number 9735665

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735795, serial/lot #: (b)(4). A medtronic representative went to the site to test the equipment. The monitor and cables were replaced. The system then passed a system checkout. The monitor was returned to medtronic for analysis. Analysis revealed that the reported issue was confirmed. When the monitor was powered on with no video animation, the monitor functioned normally, but with video animation the monitor went to a blank/black screen after running for a minute. 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. The cables were also returned to medtronic for analysis. No failures were found. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the main cart monitor was flickering. There was no patient involved.

• Brand Name: STEALTH 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: 9873929
• MDR Text Key: 184730558
• Report Number: 1723170-2020-01047
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/24/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse