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

Model Number FUSION

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 a medtronic representative, following-up at the site, reported that the registration was not lost on re-boot; the site selected the navigation system exam to register on the second time, however, before the surgeon had registered on a non-navigation system exam with only ~30slices.On (b)(6) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a pituitary tumor resection case the system became unresponsive while they were navigating.In trouble-shooting, the medtronic representative noted they were unable to click anywhere on the screen.Re-booted the navigation system and clicked the same patient exam that they had been working on, and found that the registration was no longer present.The patient was re-registered and the procedure was continued without further issue.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

The software investigation found that although the software logs did not specifically indicate a specific cause of the reported issue, the symptom was consistent with an existing software investigation.This issue was documented in a medtronic navigation software anomaly tracking database.

• Brand Name: FUSION 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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6190819
• MDR Text Key: 62912057
• Report Number: 1723170-2016-05765
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001284
• 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: 02/08/2017

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: FUSION
• Device Catalogue Number: 9733560XOM
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2009
• 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: 46 YR
• Patient Weight: 75