MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM; EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number FUSION COMPACT

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Return requested.Replacement computer shipped to site 02/01/2017.No parts have been received by manufacturer for analysis.On 02/03/2017 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No further issues have been reported.

Event Description

A medtronic representative reported that a site's navigation system touchscreen becomes unresponsive at multiple points in the software.Re-booting did not resolve the issue.This happened multiple times and at different points in the software (select patient, set-up equipment).The mouse would move to the correct location, however, the medtronic representative was unable to actually press any buttons.No further details regarding the behavior, or specifically when it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

Suspect computer was returned and testing performed: the computer powered up without issue.The touch function was normal.Able to move through the software without issue.The touchscreen function was slightly off, but after calibration the touch function was normal.No problem found.

• Brand Name: MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
• Type of Device: EAR NOSE AND THROAT 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: catherine eaton ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 6370346
• MDR Text Key: 68769406
• Report Number: 1723170-2017-00808
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00643169672956
• UDI-Public: 00643169672956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153247
• 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: 05/05/2017

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: Health Professional
• Device Model Number: FUSION COMPACT
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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