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

Model Number 9735665

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d references the main component of the system.Other medical products in use during the event include: product id: 9735762, software version: 2.1.0 h3, h6: no products were received by the manufacturer for analysis.  medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a cranial resection procedure.It was reported that during a cranial resection case, the site "missed the tumor" as found on a post-operative magnetic resonance imaging (mri).Non-tumor tissue was resected in place of the tumor.The patient had a follow up procedure utilizing navigation completed 2 days later and the tumor was removed.The issue occurred (b)(6) 2024.There was no impact on patient outcome.Delay in surgery was not provided.

Event Description

Additional information was received.The day after the initial surgery where the tumor was missed, the patient went back for an additional tumor resection procedure that was successful.There was no initial surgical delay.

Manufacturer Narrative

A manufacturer representative (rep) went to the site to test the navigation system.No hardware parts were replaced and the system performed as intended.Codes: b01, c19, d14 please see for additional information.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H2 - updated event date in b3.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.

Manufacturer Narrative

H3, h6) software data was received.There were three sessions on the of issue, in the first session, the site used "touch_trace" for registration and performed registration with an error metric of 1.3 millimeters (mm), and in the other two sessions, the registration was performed with the help of a medtronic imaging system.There was no abnormality observed related to the reported behavior.It was suspected that frame movement might have caused the reported behavior, but apart from that there was insufficient information to determine whether a software anomaly contributed to the reported behavior.Previously reported codes, b01, c19, 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.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: 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: 18695014
• MDR Text Key: 335249232
• Report Number: 1723170-2024-00538
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 08/26/2024

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
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/15/2024; 06/27/2024; 08/01/2024
• Supplement Dates FDA Received: 03/07/2024; 07/26/2024; 08/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SEE H11.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 94 KG