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 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.It was reported that the application software was re-installed with resolution.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced, therefore no parts were returned for analysis.

Event Description

A manufacturer representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system became unresponsive without prompt from the user.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.A medtronic representative went to the site to test the equipment.Testing revealed that the computer of the navigation system was replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.The computer of the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

Manufacturer Narrative

Correction: unique device identification (udi) inadvertently not included on supplemental mdr 1723170-2018-01355 sequence number 1.

• 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
• MDR Report Key: 7381740
• MDR Text Key: 103835272
• Report Number: 1723170-2018-01355
• 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,Followup
• Report Date: 09/20/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 05/11/2018; 09/17/2018
• Supplement Dates FDA Received: 04/19/2018; 06/07/2018; 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2011
• 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: 72 YR
• Patient Weight: 104