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

Model Number FUSION

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient age not available from the site at the time of filing.Udi and manufacturing date not available for this system at time of filing.No parts have been returned to the manufacturer at the time of filing.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The issue occurred intraoperatively during the navigate task.It was reported that the site suddenly lost axiem tracking during the case.The site had registered when the tracking stopped completely.The surgery was completed without navigation.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.

Manufacturer Narrative

Additional information: patient id and dob provided.If information is provided in the future, a supplemental report will be issued.

• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7776891
• MDR Text Key: 116896922
• Report Number: 1723170-2018-03956
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2009
• 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: 4 YR
• Patient Weight: 77