MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number I7

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the system became unresponsive on multiple occasions.Replacing the computer and reinstalling the software resolved the issue.The system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.Analysis found that the computer booted normally however bad sectors in the hard drive were found.

Event Description

Medtronic received information regarding an imaging device being used outside of procedure.It was reported that the system became unresponsive.The touch functions and mouse functions would not work on the monitors as well as the rack monitor.Rebooting the issue fixed it temporarily, but the issue reoccurred.There was no patient present at the time of the issue.

Manufacturer Narrative

Additional information: computer was tested and bad sectors on hard drive may have cause the issue.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 I7 INTEGRATED NAVIGATION 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7591633
• MDR Text Key: 110754934
• Report Number: 1723170-2018-02709
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2012
• 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