MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PATIENT TRACKER 9734887XOM NON-INVASIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734887XOM
Medical Device Problem Codes	Mechanical Problem (1384); Biocompatibility (2886)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3,h6) no parts have been received by the manufacturer for evaluation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used for a procedure.It was reported that the patient had a reaction to the latex sticker from the tracker.The tracker sticker that goes on the patient¿s forehead during a procedure left a red mark after it was removed from the patient's forehead.
Additional Manufacturer Narrative
H2) facility was updated.Additional information was added to b5.Medical safety assesses was reported on the reported issue and they found that per non-invasive patient tracker instructions for use (ifu) warnings include ¿carefully consider the location where you will place the non-invasive patient tracker¿ and ¿use caution and exercise care in order to prevent injury during use¿.Potential complications disclosure addendum states potential complications include tissue damage.Additionally, applicable harms and severities of harms from navigated surgery fess without inaccuracy (inherent hazardous situation) and mechanical injury are listed in harms assessment list fess.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received stating that the procedure was a sinus surgery, endoscopic, with imaging guidance, left endoscopic maxillary sinusotomy without removal of tissue, left endoscopic anterior ethmoidectomy, functional endoscopic sinus surgery (fess), with imaging guidance.There was no reported delay to the case.It appeared that the sticky part of the patient tracker took the very top layer of skin off the patient, leaving a red mark.There was no bleeding noted.The patient did have thin papery skin to begin with according to the manufacture representative.
Additional Manufacturer Narrative
Additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PATIENT TRACKER 9734887XOM NON-INVASIVE
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20491412
• Report Number: 1723170-2024-03216
• Device Sequence Number: 11651062
• Product Code: HAW
• UDI-Device Identifier: 00763000588380
• UDI-Public: 00763000588380
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: 9734887XOM
• Device Catalogue Number: 9734887XOM
• Device Lot Number: 240605A
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 05/30/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/12/2024; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female