MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733560XOM

Device Problem Output Problem (3005)

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

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: emitter 9733752, axiem 3 table top.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery.It was reported that the system was having intermittent issues tracking.Tracking was intermittent with disposable instrument tracker and patient tracker.The non-invasive patient tracker was approximately greater than 5.0mm metal interface value.They exchanged the emitter and the metal interface value decreased to 1.0-2.0mm and the procedure continued.Troubleshooting was attempted and the electromagnetic interface revealed no fault codes and tracking instruments.The power status of the axiem box was confirmed.The metal interface value continued to fluctuate and it was confirmed there was no metal in the field.A demo model was held in the air with the emitter away from the bed and the metal value was still fluctuating.They were able to verify the registration probe after fifteen seconds but no other instruments.There was a procedure delay of less than one hour and no impact to the patient at the time of the event.

Manufacturer Narrative

Additional information was received stating that due to covid-19 further information in regards to this case is not available.Codes have been updated to reflect this.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery.It was reported that the system was having intermittent issues tracking.Tracking was intermittent with disposable instrument tracker and patient tracker.The non-invasive patient tracker was approximately greater than 5.0mm metal interface value.They exchanged the emitter and the metal interface value decreased to 1.0-2.0mm and the procedure continued.Troubleshooting was attempted and the electromagnetic interface revealed no fault codes and tracking instruments.The power status of the axiem box was confirmed.The metal interface value continued to fluctuate and it was confirmed there was no metal in the field.A demo model was held in the air with the emitter away from the bed and the metal value was still fluctuating.They were able to verify the registration probe after fifteen seconds but no other instruments.It was determined that the emitter from fusion 2 was too close and the interference was causing the intermittent t racking of the patient and instrument trackers.There was a procedure delay of less than one hour and no impact to the patient at the time of the event.

• Brand Name: FUSION¿ ENT NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9433991
• MDR Text Key: 183091694
• Report Number: 1723170-2019-05901
• Device Sequence Number: 1
• Product Code: PGW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2020

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: Health Professional
• Device Model Number: 9733560XOM
• Device Catalogue Number: 9733560XOM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/02/2020; 03/30/2020
• Supplement Dates FDA Received: 01/06/2020; 04/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2011
• 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