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

Model Number FUSION

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2018

Event Type  malfunction  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.

Event Description

A medtronic representative reported that while outside of a procedure, the emitter on the navigation system was to the touch.There was no patient present when this issue was observed.

Manufacturer Narrative

Additional information: device manufacturer date provided.Correction: unique device identification (udi) updated to proper value.A medtronic representative went to the site to test the equipment.It was reported that the emitter of the navigation system was replaced to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Manufacturer Narrative

The field generator was returned to the manufacturer for evaluation.No fault was found with the returned part during functional testing and visual/physical examination.The reported issue could not be reproduced.The system remained in green status throughout testing.

Manufacturer Narrative

Review of this event and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

• 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: erika mitchellette ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7228396
• MDR Text Key: 98632659
• Report Number: 1723170-2018-00449
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2018

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: Physician
• Device Model Number: FUSION
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 01/30/2018; 03/23/2018; 08/10/2018
• Supplement Dates FDA Received: 02/20/2018; 04/04/2018; 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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