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

Model Number FUSION

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date and udi is unavailable.A medtronic representative went to the site to test the equipment.After testing, isolation transformer and power cable were replaced.The system then passed the system checkout and was found to be fully functional.The suspected isolation transformer was returned to the manufacturer for analysis.Analysis found that there was no physical damage, and no issue found.Unable to replicate the issue.The suspected main cable was returned to the manufacturer for analysis.Analysis found that the cable passed a continuity test with no opens or shorts detected.Unable to replicate the issue.

Event Description

Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during the navigate task of a functional endoscopic sinus surgery (fess) procedure, the system rebooted on its own twice.A manufacturer representative checked out the isolation transformer and all connections seemed fine.The representative was unable to replicate the issue.It was noted that the power cable had some abnormalities.The procedure was successfully completed with a delay of approximately 20 minutes.There was no reported impact on patient outcome.

Manufacturer Narrative

Additional information: device manufacture date provided.Product, unique device identification (udi) and related fields updated to proper value.

• 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 ; 7208903200
• MDR Report Key: 7610219
• MDR Text Key: 111440084
• Report Number: 1723170-2018-02825
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169504394
• UDI-Public: 00643169504394
• 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
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2008
• 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: 53 YR
• Patient Weight: 89