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

Model Number FUSION

Device Problems Data Problem (3196); Intermittent Communication Failure (4038)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that when attempting to load an exam via disc, the system would not read the disc.The site attempted to load via unstructured alternate module, but the system would say reading disc and then never provide the option to load the exam.Other discs were working fine at the site.There was no patient present when this issue was observed.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The imaging 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: koko tyler ; navigation customer quality; 826 coal creek circle; louisville, CO 80027 ; 7208903200
• MDR Report Key: 7837478
• MDR Text Key: 118924924
• Report Number: 1723170-2018-04343
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169518452
• UDI-Public: 00643169518452
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• 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: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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