MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION¿ S8 PLANNING STATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9735894
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: foreign country - australia.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 during a catheter placement procedure.It was reported that it was determined that the burr hole for the catheter placement differed from the planned trajectory, an inaccuracy of 4.3mm.This caused the biopsy to occur in the incorrect location likely resulting in a bleed.Blood was seen coming out of the top of the bone anchor, prior to the catheter being placed, indicating that the bleed occurred during the biopsy.Two possible reasons for the inaccuracy of the burr hole placement was that the crw stereotactic head frame had slipped from the planned coordinates.Or the head pins of the frame had slipped from the position they were in during the initial ct frame registration.The surgeon made the decision to abort the laser ablation and do an open craniotomy to fix the bleed and remove the intended lesion.There was a delay of one hour or longer.
Event or Problem Description
Additional information was received: the system being used was a planning station.
Additional Manufacturer Narrative
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
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
The site uses the planning station prior to and during the procedure.They use the planning station to generate the coordinates for the frame.
Additional Manufacturer Narrative
D10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735762, version: 2.0.0 h2: updates to section d.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
H2: the software version has been updated to 2.1.0.H2/h6: the software analysis has been completed.It was determined that there was insufficient information to determine if the software contribute to the cause of the issue.Codes b01, c19, and d15 apply.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: STEALTHSTATION¿ S8 PLANNING STATION
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21935002
• Report Number: 1723170-2025-01814
• Device Sequence Number: 7837374
• Product Code: HAW
• UDI-Device Identifier: 00763000423179
• UDI-Public: (01)00763000423179(11)230426
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/24/2025

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 Model Number: 9735894
• Device Catalogue Number: 9735894
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 05/18/2025; 06/04/2025; 07/24/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/16/2025; 05/19/2025; 06/05/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male