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 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9731203, serial/lot #: unknown, ubd: unknown, udi#: unknown.A medtronic representative went to the site to test the equipment.Testing revealed that parts were replaced.The system then passed the system checkout and was found to be fully functional.An update was provided that after replacing the emitter, the tracking was still intermittent.For testing, a new patient tracker and instrument tracker was opened.The instrument tracker consistently flickered no matter what port was used.The patient tracker tracked without issue no matter what port was used.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess).It was reported that intra-operatively, the surgeon was having difficulty tracking instruments.The issue was only observed when tracking instruments with the instrument tracker, and not with any of the tip-tracked plug-n-play instruments.The site swapped instrument trackers with no resolution, and moved the emitter around a lot with limited success.It was noted that the surgeon was left-handed and that the operating room (or) setup was different from the other surgeons who do not have the same issues tracking.It was suspected that there was possible metal interference from the changed setup.The surgeon proceeded with tracking the tip-tracked instruments.The procedure was completed using the navigation system and there was no reported impact to patient outcome.There was a reported delay to the procedure of forty-five minutes due to this issue.Additional troubleshooting showed that the intermittent tracking occurred when the emitter and instrument trackers were held away from everything else using known good instrument trackers.The em interface showed no problems with the emitter, axiem box, or coils of the tracker itself.It was noted that the coil values were high.It was suspected that the emitter was the cause of the reported issue.

Manufacturer Narrative

Additional information: additional information received that the issue did not resolve with the replacement of the emitter.The em interface was checked and it was discovered that there was a single fault listing.Another emitter was being sent to the site.The lot number for 9731203 was 0400009341.The emitter (product id: 9731203, lot 0400009341) was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.Tracking remained consistent throughout the duration of testing.The emitter (product id: 9731203, lot 0400004309) was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.Tracking remained normal throughout testing.The electromagnetic localization system (product id: 9733320, lot 0200066729) was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.Tracking remained consistent on all four ports throughout testing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that the new emitter resolved the issue.If information is provided in the future, a supplemental report will be issued.

• 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: 8969865
• MDR Text Key: 156818268
• Report Number: 1723170-2019-04781
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• 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
• Date Manufacturer Received: 10/07/2019
• 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
• Patient Age: 35 YR
• Patient Weight: 95