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

Model Number FUSION

Device Problems Erratic or Intermittent Display (1182); 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

A medtronic representative went to the site to test the equipment.The software and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced in the system.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that the trace points were showing on the model, but after the trace was complete they would disappear and the trace would fail.The surgeon stated he had moved the emitter and rebooted the software without resolution.The surgeon also stated the scan and 3d model looked good.There was no patient impact reported and a delay to surgery of less than one 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: 7583715
• MDR Text Key: 110574381
• Report Number: 1723170-2018-02622
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994380005
• UDI-Public: 00613994380005
• 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?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2008
• 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: 39 YR
• Patient Weight: 116