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

Model Number 9735665

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880); Audible Prompt/Feedback Problem (4020)

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

Event Date 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

H3, h6: no hardware parts have been returned for analysis.B17, c20, d15 are applicable.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735843, serial/lot #: - ; product id: 9735798, serial/lot #: -; h6: multiple annex g codes were reported.G02027 corresponds to concomitant product 9735798 that comprises the reported event.G04018 corresponds to concomitant product 9735843 that comprises the reported event.H6: multiple fdd/annex a codes were reported.A0901 was coded for the secondary beeps that could not be heard.A1102 was coded for the localizer not connected.A0902 was coded for no lights illuminated on the camera.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 the system was displaying "localizer not connected".The manufacturer representative swapped cart-to-cart cables with no effect.Multiple reboots attempted with no effect, and the manufacturer representative re-sat the ethernet connection at bulkhead inside the camera cart mast.No lights illuminated on the camera, and camera cart monitor displayed the expected video.When booting the system, the manufacturer representative reported the secondary beeps cannot be heard.The manufacturer representative removed covers from the camera cart, and poe injector light was red the manufacturer representative resat ethernet cable that runs up the mast with no effect.The manufacturer representative bypassed the internal ethernet cabling chain with no effect.The manufacturer representative swapped to a different ethernet cable with no effect.The manufacturer representative confirmed ethernet cables "clicked" when seating into the respective ports on the poe injector and camera. there was no patient involvement.

Manufacturer Narrative

Product 9735798 was returned to the manufacturer unused and is not relevant to this complaint.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

H2) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: (b)(4), serial/lot #: unknown, product id: (b)(4), serial/lot #: unknown, product id: (b)(4), serial/lot #: unknown h2-3) the component was returned to the manufacturer for evaluation.After functional testing and visual/physical examination, the reported issue was not confirmed.The results of the analysis concluded that there was no failure found.Codes: b01, c19, d14 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18886927
• MDR Text Key: 337453718
• Report Number: 1723170-2024-00774
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• 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