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

Model Number 9735669

Device Problem Connection Problem (2900)

Patient Problem Nerve Damage (1979)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 9735960, serial/lot #: (b)(4).No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a cranial resection.The procedure was a lateral skull base surgery with nerve monitoring and image-guided navigation.It was reported that the side emitter was kept disabled throughout and was only activated briefly to take measurements.This was done after identifying interference between the nim and emitter on the navigation system.The side emitter was kept switched off by switching the toggle off from the touch screen emitter menu.When the surgical team requested, the side emitter was switched back on to take navigation measurements then switched off again.When the side emitter of the navigation system was active, the patient interface monitoring appeared to be silenced without any interference detected on the nim or the navigation system.The silencing effect was detected by tap tests on the electrode surface leading to no monitoring spike on the nim.The health care professional (hcp) was concerned that there may have been emitter interference that may have led to inadequate nerve monitoring as at the end of the procedure, because there was a suspected facial nerve injury.It is unknown the extent/range and inability to view the interference on nim monitor or navigation screen, (except by tapping the electrode site) it was also troubling for the hcp.The nim was setup for parotid, per usual procedure, placed against a wall, approximately 2m from the navigation system, 2m from the side emitter, plugged directly into a single outlet.The patient interface was initially placed on the same side of the patient's head as the side emitter, within 30cmof it, it was then moved to the opposite bedside and further from the head.Navigation was aborted causing more than an hour delay in the case.Patient was impacted.

Manufacturer Narrative

H2) additional information was received and added to the event description.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.

Event Description

Additional information was received stating that it was unknown if the injury was permanent, it will take some time to determine if the injury is permanent according to the health care professional.The nerve was anastomosed before the end of the case to prevent any permanent injury.If there was permanent damage to the nerve it could be facial nerve palsy, but it is not known at the moment as a repair was done during the case.The patient was kept in the hospital for 1 week per normal protocol for this procedure.The patient was doing well when the manufacturer representative up on them on november 13th.Additional information was received stating that it was confirmed with the site that there was no patient harm.

• 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: 10851312
• MDR Text Key: 216596390
• Report Number: 1723170-2020-03001
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other