MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGUS PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733157
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used for a cranial biopsy procedure.It was reported that the probe would not track when in the camera's field of view.If covering one sphere, the probe would show as "yellow" in the tracking view.With all four spheres showing, the instrument would disappear from tracking.The account had another probe that worked without issue.The manufacturer representative said there very well could be physical damage to the instrument.This occurred intraoperatively, and there was a surgical delay of five minutes.There was no reported impact to patient outcome.Additional information was received.The most likely / suspected cause of the event was the probe was mishandled at the facility and the probe was bent.
Additional Manufacturer Narrative
H3: hardware analysis was completed on the returned probe.With markers attached and fully seated, the returned probe displayed a high geometry error that would not allow tracking.The support arm for marker #4 was bent causing the high geometry error.Otherwise, removing the #4 marker allowed the probe to have normal tracking and verification.This regulatory report is being submitted due to a retrospective review through capa 624932.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.
Additional Manufacturer Narrative
The initial regulatory report was submitted due to retrospective review through capa 624392, not the previously listed 624932.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: NAVIGUS PROBE
• 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: 20758120
• Report Number: 1723170-2024-03650
• Device Sequence Number: 12867339
• Product Code: HAW
• UDI-Device Identifier: 00613994231413
• UDI-Public: 00613994231413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K971247
• 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): 12/12/2024

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 Model Number: 9733157
• Device Catalogue Number: 9733157
• Device Lot Number: 151124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 102 KG