MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PLUS SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735667

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identification (udi) is unavailable.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.No part returned for evaluation/analysis.

Event Description

A medtronic representative reported that, while outside of a procedure, the navigation system received an error indicating a "low performance" and the screen would go blank.Troubleshooting involved trying to replicate the issue and pinching to zoom out.It was later identified that no images were being zoomed in at the time of the issue.The issue had occurred during testing and video recording and not clinically.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: device manufacture date and unique device identification (udi) provided.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was reported that there was no failure found with the system, no hardware components were replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3, h6: a software analysis was initiated to determine the probable cause of the issue.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.Fdm 10, fdr 104, and fdc 4307 are applicable to the software analysis.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 S8 PLUS SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7315524
• MDR Text Key: 101705260
• Report Number: 1723170-2018-00735
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/12/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 9735667
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 05/01/2018; 05/01/2018; 10/28/2020
• Supplement Dates FDA Received: 03/15/2018; 05/29/2018; 11/21/2019; 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1