MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problems Imprecision (1307); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The system was serviced in the field and passed all tests.No failures were found.Logs and archives were received however analysis has not been completed.Concomitant medical products: product id: 9735736, version 1.0.1.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a transsphenoidal procedure.It was reported that there were several issues with registration.The first registration failed.After this, the site traced and got a value of 0.7, however there were some inaccuracies on one side of the inner canthus.The surgeon added more points on this side to improve accuracy but there was no change.The surgeon even used a few touch points.The registration was restarted.When the local representative (cs) went to add the fiducial points back, she clicked the greyed out fiducial and it automatically turned green as if it had been collected.The same added to another point.The system was rebooted and registration was attempted again, but there was still some inaccuracy one side of the canthus, about 3mm off.There was a reported delay to the procedure of less than one hour.There was no reported impact to the patient.It was reported that accurate registration was not possible.There was still a slight inaccuracy.The surgeon decided to continue with the slight inaccuracy an accounted for it.The cause was not identified.

Manufacturer Narrative

H3, h6: the software investigation was unable to determine probable cause.The archive was reviewed and registration of.8 mm of accuracy was verified.Green zone covered left side of the anatomy.Suggesting to take more points to cover the complete nose area.Reviewed the registration of 5.1mm accuracy and there were only few trace points taken and the points which are on the right side of the anatomy are bit deeper into the skin.Suggesting to collect more points on the blue area.Reviewed the registration of 2.1mm accuracy where it is not green zone and yellow zone almost covers entire anatomy.Also, the points on the left side are bit deeper into the skin.Suggesting to collect points on the bony areas which covers entire blue region as per the protocol.There is insufficient information to determine whether a software anomaly contributed to the reported behavior.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.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 SYSTEM
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11020682
• MDR Text Key: 221801195
• Report Number: 1723170-2020-03298
• Device Sequence Number: 1
• Product Code: PGW
• 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
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 12/15/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 118