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 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

On 11/16/2016 software engineer analysis of patient logs revealed an error occurred that caused the unexpected exit.Software investigation was completed.This issue was documented in a medtronic software anomaly tracking database.Return requested.Replacement equip rack i7 transceiver, nav interface i7 transceiver, i/o hub i7, usb optical extender kit and i7 nav interface cable clamp were all shipped to site 11/21/2016.No parts have been received by manufacturer for analysis.On 11/29/2016 a medtronic representative performed a navigation system check-out, software and instruments areas passed.Hardware test failed.Navigation system continued to lock and become unresponsive.Replaced transceivers with upgraded transceivers and issue was resolved.System performed as intended.

Event Description

A medtronic representative reported that, while in a cranial procedure, the surgeon alleged their navigation system became unresponsive.A medtronic representative recommended re-starting the navigation system to restore normal function.The site re-started the rack, but left the navigation interface unit (niu) on and this resolved the issue.The unresponsive screen occurred during navigation when the surgeon requested to switch to a microscope probe and when he tried to navigate with the probe the software was unresponsive and the touch screen was not responding.The site then re-started the rack computer and logged back into the cranial optical software and it worked and tracked normally.The niu was left on during this procedure.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was 5 - 10 minutes.There was no impact on patient outcome reported.

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 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: 6171911
• MDR Text Key: 62319616
• Report Number: 1723170-2016-05684
• 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

• 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
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 02/23/2017
• 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: 13 MO
• Patient Weight: 7