MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TRACKER 9733533XOM ENT INSTRUMENT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733533XOM
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information has been asked but is unknown at this time.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used intraoperatively during a functional endoscopic sinus surgery (fess).It was reported that the patient was able to be registered by trace method without any issues.Once the instrument tracker was moved to the straight suction, it was verified in the divot of the non-invasive patient tracker without issue.However, the straight suction failed to navigate within the electromagnetic (em) field.The display was static and the cross hairs remained red.No excess metal was identified in the em field.The position of the side emitter was both checked and adjusted to a new position but that was unsuccessful.The instrument tracker was moved to the 70 degree suction and was verified but the same issue with no navigation and red cross hairs continued.Ultimately, the surgeon moved on with performing the surgery without navigation after 10 minutes of trying to fix the problem.After speaking with the nursing staff who were in the operating room (or) during the system issue, it was believed that the physician did not progress the software to the 'navigation' screen.It was believed that the surgeon attempted to navigate with the suctions in the accuracy confirmation screen and was not paying attention to the system warnings that the suction instruments could not be used in the accuracy test screen.There was a surgical delay of less than one hour.There was no patient harm.
Event or Problem Description
Additional information was received.A medtronic representative reported to technical services (ts) that he believed that the customer was attempting to use various instruments and navigate in the patient registration confirmation screen.He observed a different case and there were no issues appreciated.
Additional Manufacturer Narrative
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: TRACKER 9733533XOM ENT INSTRUMENT
• 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: 14470199
• Report Number: 1723170-2022-00784
• Device Sequence Number: 4569694
• Product Code: PGW
• UDI-Device Identifier: 00763000588342
• UDI-Public: 00763000588342
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K001284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 01/26/2024
• Device Model Number: 9733533XOM
• Device Catalogue Number: 9733533XOM
• Device Lot Number: 220126D
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2022
• 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 Age: 36 YR
• Patient Sex: Female