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

Model Number 9735669

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

Patient age not available from the site.Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.Concomitant medical products: product id: 9735521, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a temporal lobe tumor procedure, inflammation was observed around the midline of the lower jaw skin.It was reported that the issue occurred after about seven hours of the procedure.It was reported that there was no direct contact on the patient with the emitter.Additionally it was suspected that the emitter contributed to the inflammation.There was no reported delay to the procedure due to this issue.

Manufacturer Narrative

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.

Event Description

Additional information was received.It was reported that the issue occurred on a demo device.It was noted that the redness was observed on the skin in the center of the lower jaw and developed when the drape was removed after prolonged surgery.It was clarified that there was a query from the customer on whether the emitter contributed to the inflammation.It was noted that a hospital visit could not be made, so the patient's condition could not be confirmed.

• Brand Name: S8 ENT STEALTHSTATION NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9897540
• MDR Text Key: 188826171
• Report Number: 1723170-2020-01102
• 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
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention