MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9736242

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.Information references the main component of the system.Other relevant device(s) are: product id: 9735762, vresion #: 2.0.0, ubd: , udi#: h3) the manufacturer representative went to the site to test the navigation system.After discussion with the site it was found that the cables were placed onto the flat emitter.This caused interference.Additional information was received stating that the first occurrence of interference with anesthesia was on friday, march 3rd with dr.Kim with a patient who had a pacemaker.On monday, march 6th this happened again, this patient did not have a pacemaker.To the manufacturer representatives understanding, they were both standard functional endoscopic sinus surgery (fess) cases.The site¿s concerns was ¿after placing the emitter under the patient¿s head, they could no longer determine without a doubt if the pacemaker was firing properly due to the amount of interference.It wasn¿t until the end of the case when they completely removed the emitter from under the patient¿s head that the ecg was without interference¿.The site seemed to think the flat emitter was causing interference with the ecg monitor.They also mentioned they were informing health canada about friday¿s case.The rep asked if there were any injuries to the patient, and they said although they do not follow up on this, they did not hear of any issues with recovery.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that  the health care professional was experiencing a lot of interference with anesthesia while using the flat emitter and was unable to use navigation.The patient had a pacemaker.Additional information was received stating that the procedure was no aborted and that the health care professional was able to complete it with a lot of interference.The patient was impacted, but the site did not wish to provide those details.

• Brand Name: STEALTHSTATION FLEXENT
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16619535
• MDR Text Key: 312046073
• Report Number: 1723170-2023-00457
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9736242
• Device Catalogue Number: 9736242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/27/2023
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention