MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number	9734060
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No service had been requested from the site.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used for an spine procedure.During the procedure, the instrument tool cards could not be added into the software after installing spine tools.The manufacturer representative confirmed the instrument tools did not show in the "instruments not at this site" section.Reinstall of the tools database did not resolve the issue.The reported issue resulted in approximately a 45 minute procedure delay.The procedure was completed with the use of another navigation system.Further actions included requesting uninstall/reinstall of the spine software.To date, this had not been completed.
Additional Manufacturer Narrative
Additional patient information have been received.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that the procedure was a thoracolumbar procedure.
Additional Manufacturer Narrative
D10/h2/h3/h6: logs were returned for analysis.The logs were reviewed but provided no additional insight regarding the cause of reported complaint.Codes 10, 213 and 4315 are applicable to this.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 I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9892334
• Report Number: 1723170-2020-01097
• Device Sequence Number: 1800334
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2020

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: Health Professional
• Device Model Number: 9734060
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 05/22/2020; 08/17/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 06/01/2020; 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 85