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

Model Number FUSION

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern. No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that, while outside of a procedure, the emitter would intermittently experience difficulties tracking instruments when there was no metal interference. There was no patient present when this issue was identified. No additional information was provided.

Manufacturer Narrative

The field generator was returned to the manufacturer for analysis. The field generator was connected to a known good axiem test system for a twenty four hour burn-in test. The system remained in green status throughout all testing. The reported problem could not be duplicated.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment. Testing revealed that a field generator was replaced to resolve the issue. The system then passed the system checkout and was found to be fully functional.

• 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: 7370570
• MDR Text Key: 103462474
• Report Number: 1723170-2018-01313
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/26/2018
• 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?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse