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

Model Number FUSION

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. It was unable to duplicate the issue; however, the system failed the hardware checkout but passed the software and instrument checkout. The emitter was replaced, and system performed as intended. The imaging system then passed the system checkout and was found to be fully functional. No parts have been returned to the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used outside of procedure. It was reported that when trying to track the instrument tracker it will flicker in and out while moving it slowly a fists distance from the emitter. When the patient tracker moves the same thing occurs.

Manufacturer Narrative

The field generator was returned to the manufacturer for analysis. The unit was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7582903
• MDR Text Key: 110512046
• Report Number: 1723170-2018-02612
• Device Sequence Number: 1
• Product Code: HAW
• 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: 07/17/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse