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

Model Number I7

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(6) 2016 software investigation was completed.The logs were reviewed, and a core file revealed that an error occurred in libqtcore.So.4, one of the gui libraries.This issue was found related to a software issue and was documented in a medtronic software anomaly tracking database.On (b)(6) 2016 a medtronic representative, following-up at the site, reported they used the navigation system for an hour without any issues.While navigating, they brought the axiem stylet into the emitter field of view (fov) and it did not track though it had been tracking consistently for the last hour.They replaced it with another stylet in the same axiem port and that one also did not track.The site then attempted to move back in the software, however, the software first went to a blue screen, then blinked black, then went to the blue logo screen and stayed there.Site then performed a hard shut-down of the navigation system, both the niu and the rack, normal function was restored.Return requested.Replacement computer shipped to site (b)(6) 2016.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a axiem cranial resection procedure, the site's navigation system became unresponsive in the navigate task.The site booted the navigation system down and back on and the issue was resolved.No further details regarding the behavior were provided.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was 5 minutes.There was no impact on patient outcome.

Manufacturer Narrative

The i/o hub was returned to the manufacturer for analysis.The i/o hub was tested on bench tester and was found to be working as expected.I/o hub was updated with new rev.Due to compatibility issues when updating rack and niu transceivers.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The usb optical extender kit and i7 nav interface cable clamp were returned unused and unrelated to the cause of the reported event.The computer, equip rack transceiver, and nav interface transceiver have been received and are currently under analysis.

Manufacturer Narrative

The suspect computer was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The equipment rack transceiver was returned to the manufacturer for analysis.Testing found that the reported issue could occur, but the freezing was linked to a software issue.The nav interface transceiver was returned to the manufacturer for analysis.When paired with the equipment rack transceiver, the reported issue could be replicated and could be linked to the software investigation conducted by medtronic representative.

• 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: peter verhey ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6149969
• MDR Text Key: 61594665
• Report Number: 1723170-2016-05666
• 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,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• 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: 01/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2010
• 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
• Patient Age: 28 YR
• Patient Weight: 69