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

Model Number 9736242

Device Problems Electromagnetic Interference (1194); Material Integrity Problem (2978)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation device being used in a functional endoscopic sinus surgery (fess).It was reported that a patient came to the site for a image guided sinus surgery.The image guidance machine had a flat electromagnetic emitter which was placed under the patients head.This emitter allows the system to recognize anatomically where the image guided instruments are within the patients sinuses.This patient had an implanted pacemaker.Prior to the placement of the emitter under the patients head, the patient had a paced rhythm at 60.After setting up all of the equipment for the procedure, the health care professional (hcp) notified the manufacturer representative (rep) that there was a lot of artifact noted on the ecg monitor.The hcp thought it may be due to the emitter.The rep unplugged the emitter but this did not help.The patient¿s vital signs were stable according to anesthesia so they elected to carry on with the procedure.As a precaution anesthesia requested the crash cart be brought into the o.R.In case they needed to externally pace the patient.The case was completed without any other issues identified.It was noted that at the end of the case when the flat emitter was removed from under the patients head that the artifact previously identified had now disappeared.Anesthesia had ask to follow up with the patient post-op.An entry was made into the patient¿s intra-op record identifying the issue and pacu staff were notified in advance in order to prepare for the patients arrival.2023-mar-06 additional information was received stating that after the incident report, the site checked the image guided system in the operating room while the device was in use.At that time the patient¿s ecg waveform on the display was good.No distortion nor artifact detected.The patient didn¿t have a pacemaker.Anesthesia was told that they had lots of artifacts on the same patient¿s ecg waveform.However it went away before the site got in the operating room.Anesthesia selected the pacer option on the monitor and showed the artifacts to site.At the time of incident patient ecg cables ran around the patient head and it was touching the emitter.The site performed the following test to confirm the issue.The simulator set to 60 bpm and the patient monitor pacer detection turned on.The emitter of the navigation system was on off position.The clean waveform on the patient monitor confirmed.The emitter turned on and the simulator moved close to the emitter.The artifices could be seen on the patient monitor when the simulator was 6 inch away from the emitter.As the ecg cables moved away from the emitter, the artifacts were disappeared on the monitor screen.The issue was confirmed that the emitter had a magnetic field and ecg cables pick up the electrical noise from the magnetic field.They could not confirm the pacer markers and r wave as the artifact was displayed by monitor as pacer spikes.(b)(6) 2023 medtronic field service engineer and clinical specialties checked the system and they confirmed the issue.They used another emitter and the issue was still persistent.(b)(6) 2023 during the testing the patient monitor picked up the artifact if the ecg cables closed to the electromagnetic instrument interface.They observed that the patient monitor would pick up the artifact from the magnetic field, and then would filter the noise.The test confirmed that both the emitter and the instrument interface module create magnetic field.By measuring the artifact intervals on the patient monitor the display observed that the emitter induces the noise in the fixed frequency of 5 hz.If the patient monitor pacer option being selected, then this artifact can displayed on the patient monitor as pacer spikes.In the general summary of the failure the service report identifies an ¿ecg machine¿.The physiological monitor that was used during the procedure and testing is not an ecg machine.With regards to the following statement in the service report, ¿as per the service manual, position the system and emitter as far from patient monitoring devices and use filtering if possible.The site requested the service manual however this request denied by medtronic inc.The site did not have a service manual to confirm and the customer repair manual provide by medtronic inc.Doesn¿t have any reference to the statement in the service report that can be identified.The site also indicated that there was no specific training with regards to routing of the patient applied accessory cables.

Manufacturer Narrative

The manufacturer representative went to the site to test the navigation system.There was no physical damage to the system or the ecg leads.The service manual was not available for the site to confirm and test the functionality of the device to ensure it conforms to manufacture performance specifications.Additional information was received stating that there was an issue with ecg artifacts from the flat emitter and ecg machine.Upon checking the navigation system they found that the emitter caused ecg interference when the cables were routed in close proximity to the emitter.When checked with two different emitters the same issue occurred.It was stated that this cause concern to patient safety, especially if a patient had a pacemaker.The interference could affect p wave and r wave readings.The manual states that the position of the system and the emitter as far from the patient monitoring devices and use filtering if possible.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 16619780
• MDR Text Key: 312418209
• Report Number: 1723170-2023-00462
• 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?: No
• 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?: No
• 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