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 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Unique device identifier (udi) is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.Device manufacture date is unavailable.

Event Description

Medtronic received information that, while in a functional endoscopic sinus surgery (fess), the ear, nose & throat (ent) application software became unresponsive without prompt from the user.It was noted that restarting the navigation system restored functionality.There was a reported delay to the procedure of ten minutes 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.Product and related fields updated to proper value.A software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis 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

Additional information: patient demographics.

• 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 80027-9710 ; 7208903200
• MDR Report Key: 7626686
• MDR Text Key: 111986296
• Report Number: 1723170-2018-02927
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

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: 05/29/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 08/01/2018
• Supplement Dates FDA Received: 07/25/2018; 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2008
• 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: 49 YR
• Patient Weight: 54