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

Catalog Number 9735665

Device Problems Computer Software Problem (1112); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

No parts have returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while in a cranial resection procedure the navigation system displayed a low performance message and yellow caution sign.The system restarted itself.There were multiple images merged.After restarting the system, the same issue occurred.If the models are hidden, the system works properly.There was a reported delay to the procedure of less than 1 hour due to this issue and no impact on the patient outcome.

Manufacturer Narrative

The archive from the procedure was sent to medtronic for evaluation.Testing found that the issue could be replicated when loaded onto a known operational navigation system.

Manufacturer Narrative

The logs for the navigation system were reviewed by medtronic personnel.The logs showed that the reported issue had occurred.However, no additional insight into the probable cause was located.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system passed all functional testing and visual inspection.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding navigation device being used for cranial resection.It was reported that the system displayed a low performance message and a yellow caution sign appeared during the case and the system rebooted itself.It was noted that multiple images were merged.While troubleshooting it was reported that after restarting the system, the issue persisted.System would function normally if the models were hid.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No known impact on patient outcome.

Manufacturer Narrative

Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: 9 735737, version #: 1.0.2 h3) the software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.The record was closed with the release of the new software version 1.2.0 which incorporated the fix for this anomaly.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 PREMIUM SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7218582
• MDR Text Key: 98213650
• Report Number: 1723170-2018-00389
• 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: 08/17/2020

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: Physician
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 04/02/2018; 04/26/2018; 04/26/2018; 08/14/2020
• Supplement Dates FDA Received: 04/17/2018; 04/27/2018; 02/07/2019; 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 65