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

Model Number FUSION

Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Udi and manufacture date not available for this instrument at time of filing.A medtronic representative went to the site to test the equipment.The system failed the hardware checkout but passed the software and instrument checkout.The axiem box was changed and it resolved the issue.The imaging system then passed the system checkout and was found to be fully functional.The axiem system controller was returned to the manufacturer for analysis.Analysis found that the reported issue was confirmed.The axiem, emitter and tool ports, all showed a red status.The 12vdc power supply shows a ¿fault¿¿.As well as, multiple other drive faults displayed.Analysis found that the reported event was related to an electrical issue.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.The field generator was returned to the manufacturer for analysis.The issue could not be duplicated.There was no fault found with the field generator.

Event Description

Medtronic received information regarding a navigation device being used for functional endoscopic sinus surgery (fess).It was reported that the axiem communication was completely lost.Everything was in red status.They did reboot the system which did not resolve the error.Navigation and imaging were aborted, but there was no additional patient impact reported.There was a delay to surgery of less than 1 hour.

• 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: tiberious mose ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7584062
• MDR Text Key: 110576778
• Report Number: 1723170-2018-02625
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

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: 05/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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