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

Model Number	9733533XOM
Medical Device Problem Codes	Device Sensing Problem (2917); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa: 624392.A0709: registration issues a22: verification issues f26: no patient impact f1908: delay of less than one hour h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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 during a functional endoscopic sinus surgery (fess) procedure.It was reported the site was having issues registering.After successfully registering at 2.3mm, the straight suction would not verify.The ear, nose/throat (ent) tracker on the straight suction would not go below 3.5mm.The site had used a total of two ent trackers that would not go below 3.5mm.At first they did not add the straight suction to the equipment list as well.Troubleshooting was done and technique was bad at first.Technical services (ts) had the site start at the tip of the nose and only trace on the hard surfaces and that gave then a successful registration.The other registrations were not accurate in verify accuracy (5.0 mm, 6.2 mm, 4.2 mm,4.1 mm) and the lines were not on the nose or the forehead they were on the cheeks and eyes.The points looked sunk in as well.Ts noticed this due to the yellow circle of accuracy showing up behind the nose area.After the doctor traced lighter and stayed on the hard surfaces accuracy was at 2.3mm.The image had most of the forehead gone as well.Ts had to change them to trace.They were originally on patient tracker.Three point trace would not line up once they went to the second blue dot.Ts had to change the back to trace and work on their tracing technique (that was when they traced on hard surfaces and registration was successful).The gel donut was removed from under the patients head as well.There were green lights on the breakout box as well, and would always read if it was plugged in.There was less than an hour delay in surgery.The use of medtronic imaging and navigation was aborted.The surgery was aborted.There was no other reported impact on patient outcome.Additional information was received.The surgery was not aborted.

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20906110
• Report Number: 1723170-2024-03861
• Device Sequence Number: 21121091
• Product Code: HAW
• UDI-Device Identifier: 00763000588342
• UDI-Public: 00763000588342
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: 09/11/2024
• Device Model Number: 9733533XOM
• Device Catalogue Number: 9733533XOM
• Device Lot Number: 220912J
• 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: 07/28/2023
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2022
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 137 KG