MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problems Application Program Problem (2880); Human-Device Interface Problem (2949)

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

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The navigation system passed the system checkout and was found to be fully functional.No parts were replaced on the system.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection procedure (tumor resection and lobectomy).It was reported that during the clinical case, the surgeon got a ¿low performance¿ message on the navigation system while in the verify registration task.The surgeon was having trouble getting a passing registration and was going from the registration screen to the verify registration screen several times.At one point he selected his first registration, moved forward to verify, and got "low performance." this happened a second time when selecting a different registration.They were eventually able to move onto navigate with a passing registration with high enough accuracy for the surgeon.It was also noted that during the process of selecting previous registrations, one of the past registrations recalculated from an original value of 3.1 mm registration metric to 5.4 mm.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue.Logs and archive were reviewed and provided no indication that a software anomaly contributed to the reported behavior.Software appears to be working as designed.Analysis was unable to determine probable cause and could not find any information related to issue reported.Unable to determine probable cause without further information since the on-going investigation proved to be inconclusive based on the information provided.This case may be re-opened if additional information is received.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.Technical services (ts) was unable to replicate the low performance message with the patient archive.

Manufacturer Narrative

H2) additional information: continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: 9735737, software version: 1.1.0 h3) a software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.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: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8542272
• MDR Text Key: 143298397
• Report Number: 1723170-2019-01931
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 66