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

Model Number 9735665

Device Problems Environmental Compatibility Problem (2929); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. No parts have been received by the manufacturer for evaluation. 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 camera cart monitor of the navigation system lost touch screen functionality, and powered off without prompt from the user. It was reported the monitor powered back on to the same screen without issues. There was no patient present when this issue was identified.

• Brand Name: STEALTHSTATION S8 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11049487
• MDR Text Key: 223192927
• Report Number: 1723170-2020-03363
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2020
• 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?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse