MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC EM INSTRUMENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733533
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation device being used during a functional endoscopic sinus surgery (fess.) it was reported that navigation worked well at the start of the case.Towards the end of the case, the surgeon tried to switch instruments.The instrument verified with audible confirmation as well as a "verification successful" at the bottom left, and the instruments showing at the bottom right.After about ten seconds, the bottom left would switch to the warning, "instrument not verified," and the crosshairs would remain red despite the instrument being in the field.The manufacturer representative (rep) changed the ports of both the instrument and patient trackers, the emitter was toggled off and on, navigation was exited and re-entered, and the electromagnetic (em) breakout box and emitter were unplugged and plugged back in with no success.The surgeon tried multiple different instruments, and all would verify then stop tracking.There were no issues with navigation in other cases.There was no reported delay to the procedure due to this issue.There was no reported impact on patient outcome.Additional information was received.It was reported that the use of navigation was aborted.The surgeon continued the procedure without navigation using his knowledge of anatomy.Troubleshooting was attempted at the time of the event, but it did not resolve the issue.
Additional Manufacturer Narrative
No products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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: EM INSTRUMENT TRACKER
• Common Device Name: NEUROLOGICAL 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: 15822738
• Report Number: 1723170-2022-01898
• Device Sequence Number: 6109065
• Product Code: HAW
• UDI-Device Identifier: 00613994353450
• UDI-Public: 00613994353450
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: 9733533
• Device Catalogue Number: 9733533
• Device Lot Number: 220622A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown