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

Model Number 9735665

Device Problem Human-Device Interface Problem (2949)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 9735737, serial/lot#: version: (b)(4).Device evaluated by mfr: a medtronic representative went to the site to test the equipment.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.

Event Description

Medtronic received information regarding a navigation system that was during a cranial resection procedure.It was reported that the surgeon was having difficulty registering the patient in a tumor resection case this morning.The patient had 8 fiducials placed and 6 were recognized by the software when the exam was loaded.When registering with the fiducials he was unable to get a passing registration.Surgeon then performed a trace registration which passed but then felt inaccurate.Patient was positioned on her side.Surgeon decided to have patient rescanned.Troubleshooting was performed.Attempted to combine trace points with fiducials without improvement.Edited the 3d model to remove artifact around the chin, added anatomical touchpoints, which when used with tracing but not the fiducials brought the accuracy metric to 1.7.The surgeon still felt that he was off in the posterior direction by more than he was comfortable.The site got a ct of the patient and merged it with the mri.They were able to get an acceptable registration.Looking at the mri several of the fiducial marker where compressed in the scan and some noticeable skin movement.There was a reported delay of one and half hours.There is no known impact on patient outcome.

Manufacturer Narrative

H3: analysis of the software was completed by reviewing the archives.It was shown that there were 4 mri scans, two were thickness more than 2 mm and the others had missing slices and no registration data found, but provided insufficient information to determine root cause of the reported behavior.Fdc d14, fdm b01, fdr c19.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 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11088954
• MDR Text Key: 224780817
• Report Number: 1723170-2020-03426
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 65 YR
• Patient Weight: 64