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

Model Number FUSION

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

Patient age not available from the site.A medtronic representative went to the site to test the equipment.The computer was replaced.The navigation system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information that during a functional endoscopic sinus surgery (fess) case the monitor unexpectedly went black.After rebooting the system the black monitor went away.It was noted this is not the first time this has happened and that sometimes when the site moves the mouse around the monitor will come back on.In the past when the rep has taken a look at the system he cannot replicate the issue.There was no reported impact on patient outcome.

Manufacturer Narrative

The power supply for the navigation system was returned to the manufacturer for analysis.The power supply was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The monitor was returned to the manufacturer for analysis.The monitor was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

Additional information: medtronic received additional information that the other dates and times were not provided.It was just reported from the surgeon that the issue had occurred before.

Event Description

Medtronic received information that during a functional endoscopic sinus surgery (fess) case the monitor unexpectedly went black.After rebooting the system the black monitor went away.It was noted this is not the first time this has happened and that sometimes when the site moves the mouse around the monitor will come back on.In the past when the rep has taken a look at the system he cannot replicate the issue.There was no reported impact on patient outcome.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7565839
• MDR Text Key: 109947366
• Report Number: 1723170-2018-02453
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2010
• 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: 62 YR
• Patient Weight: 83