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

Model Number 9733856

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 9734477, serial/lot #: (b)(4), udi#: (b)(4).The computer has been returned, and is currently under analysis.A medtronic representative went to the site to perform a system check out and they found that the software was becoming unresponsive when going into an axiem registration, but seemed to be fine in an optical.The panel was opened to remove the axiem usb, however as soon as the usb was removed, the screen went black with blue flickering lines at the top.A hard reboot was done.The representative replaced the computer.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 catheter placement procedure.It was reported that the staff monitor started flickering, while prepping the patient.The system was rebooted to resolve the issue.The site registered, navigated, and they got another shunt in the middle of the procedure.The system became unresponsive so another reboot had to be done.Once navigation resumed, the monitor started flickering again so a third reboot was done to resolve the issue.There was no patient harm and the procedure was not delayed over an hour.

Manufacturer Narrative

The computer was returned for product analysis.The computer booted normally to the application screen.The installed programs all started and ran normally.The cranial program was put into navigation mode for 4 hours.The system remained in green status and no unresponsiveness was observed.No video issues were observed.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3, h6: the computer 9734477 rollingstone embedded (b)(6)) has been returned to the manufacturer, however, analysis has not been completed.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
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9934111
• MDR Text Key: 186808806
• Report Number: 1723170-2020-01172
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 104