MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9733856R
Medical Device Problem Code	Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 9735225r, serial/lot #: unknown, ubd: unknown, udi#: unknown.No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the video card in the computer was failing.When the surgeon monitor was connected, the computer shut down.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
A medtronic representative went to the site to perform a system checkout.Hardware parts were replaced and the system passed checkout.(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that the cause or contributing factors related to the reported issue were unknown.
Additional Manufacturer Narrative
Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id:9734477 , serial/lot : (b)(6) h3, h6: the computer was returned for product analysis.The computer booted normally to the application screen.The installed programs started and ran normally.No automatic shutdowns were observed.No problems detected.Fdm10, fdr213, fdc67 are applicable to the computer analysis.Fdm10, fdr114, fdc4307 are applicable to the system checkout.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.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9328420
• Report Number: 1723170-2019-05630
• Device Sequence Number: 1926984
• Product Code: HAW
• UDI-Device Identifier: 00613994603678
• UDI-Public: 00613994603678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/11/2020

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: No Information
• Device Model Number: 9733856R
• Device Catalogue Number: 9733856R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 05/13/2020; 06/01/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/29/2020; 05/19/2020; 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10..."; "SEE H10...."