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

Model Number 9735894

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735737, software version #: 2.0.1 h3, h6: software analysis was performed.A software issue was confirmed.Codes b01, c10, and d02 are applicable.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 outside of a procedure.It was reported that a merge issue was found in app 2.0.1 that can be replicated with the demo exams.Workflow was as described, the deep brain stimulation (dbs) planning case, have magnetic resonance (mr) and diffusion and these merged.Created a plan on the mr.Back to images and added a frame computer tomography (ct) scan, in the merge the ct was the new reference and merge was verified.At frame registration task, the plan had now moved out of position by centimeters.But, if i happen to have 2 mr and diffusion, and make 1 mr be the reference, and the other mr be the diffusion reference and merge them, then create a plan on the reference mr.Add a frame ct, and merge make the ct be the new reference and verify.At frame registration task, the plan was still in the correct location.The problem seemed to be if the navigation and diffusion references were the same exam, changing the reference would move the plan.The manufacturer representative just replicated the issue using the demo with an mr, diffusion and ct bone in a tumor resection workflow, so it was unrelated to the dbs aspects.There was no patient involvement.Additional information was received.The problem was first reported and sample anonymized dataset provided by a hong kong medtronic representative (rep).Additional information was received.The navigation was being used during a deep brain stimulation procedure.The site tried to solve the issue but did not succeed, and eventually they used brainlab for replanning.The procedure was success with the re-plan.There was a surgical delay of almost half an hour, and there was no reported impact to patient outcome.

• Brand Name: STEALTHSTATION¿ S8 PLANNING STATION
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18530258
• MDR Text Key: 333372975
• Report Number: 1723170-2024-00102
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169946538
• UDI-Public: 00643169946538
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/17/2024

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
• Device Operator: Health Professional
• Device Model Number: 9735894
• Device Catalogue Number: 9735894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0188-2024
• Patient Sequence Number: 1
• Treatment: "SEE H10...."