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

Model Number	9734887
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess).It was reported that there were issues with verification during a case issues with verifying suctions.Attempted to verify a straight suction using instrument tracker one, and it would not verify.Attempted to verify a 90-degree suction with instrument tracker two and it would not verify.Swapped instrument tracker one to the 90-degree suction and it verified.Swapped instrument tracker one back to the straight suction and it verified.There was a reported delay of less than an hour.There was no impact to patient outcome.
Additional Manufacturer Narrative
Product analysis #703905197, (b)(6)2020, 12:48:53 cdt webmremotews sfdcmnav product analysis task update tested by date: 2020-09-02.Findings and conclusions: the returned tracker was not recognized when connected to a known good system and would not track.A check of the em interface showed all three coils firing normally.Afc: nafc0118 - damaged tool; this regulatory report is being submitted due to retrospective review through capa 643143 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: NON-INVASIVE PATIENT 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22044700
• Report Number: 1723170-2025-01999
• Device Sequence Number: 8781556
• Product Code: HAW
• UDI-Device Identifier: 00643169488113
• UDI-Public: 00643169488113
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/19/2025

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: 12/13/2020
• Device Model Number: 9734887
• Device Catalogue Number: 9734887
• Device Lot Number: 171214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 77 KG