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

Model Number 9735665

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735854 (hdmi adaptor), serial/lot #: unknown, ubd: unknown, udi#: unknown.Product id: 9735775 (hdmi to dvi cable), serial/lot #: unknown, ubd: unknown, udi#: unknown.Product id: 9735764 (computer), serial/lot #: unknown, ubd: unknown, udi#: unknown.A medtronic representative went to the site to test the equipment.Hardware parts were replaced.The system was found to be fully functional.The hdmi adaptors and the hdmi to dvi cable were returned but analysis was not completed at the time of filing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that when connecting to an external monitor it would flicker.The rep was on site after the internal wires and adapter on the i/o panel for communication were replaced and the external monitor image was clear and solid, not flickering at all.The system was tested with the tv monitor and boom equipment and it was marked as working as intended.The rep was highly suspicious that another manufacturer's equipment affects images.On (b)(6) 2020 it was reported that after the parts were replaced the system was still having issues with the secondary monitor.It was noted that the system would show a purple hue on the secondary monitor when plugged directly to the navigation system.When using another cable with an adapter they would get no video signal.After some time, both would eventually work with communication to the external monitor from the navigation system.The rep noted the same issues when being plugged into the boom system at the site as that's what they normally use for clinical cases.It was seen that this was the only system that the account was having issues with as the same hdmi cables and converters worked on the sites other stealth stations with no issues.Lastly the stealth received a external monitor disabled error on the screen but they were still able to see the video on the secondary monitor.No patient was present.

Manufacturer Narrative

H3: a hdmi adaptor (product id: 9735854, lot number: 190111) was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.Not failure was found.A second hdmi adaptor (product id: 9735854, lot number:200402) was returned to the manufacturer for analysis.Analysis found that the part was returned unused but had been used for troubleshooting.The cable was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed.No failure was found with the returned cable.The computer has been received by the manufacturer.However, analysis has not been completed at the time of filing.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

Medtronic received additional information that the issue occurred on a non-medtronic external monitor integrated room.Every monitor was tested to eliminate factors outside of the navigation system.The output signal was flickering.The cable and output port were replaced.This resolved the issue.It was noted that work had been completed on the non-medtronic monitors end as well.The computer was also reported when testing the navigation system with a non-medtronic system.There was a purple hue on the output signal.This was tested on the non-medtronic system and direct connection to the external monitor.Multiple external cables were tested.All issues were noted to be resolved.

Manufacturer Narrative

The computer 9735764 nav with pcoip s8 svc (1907c01216) was returned for analysis.Analysis found no fault with the returned computer.The computer powered on when power was applied.After multiple power cycles no boot up or video issues were observed.The network configuration was set correctly and all display ports-dvi, hdmi and dp functioned correctly.The sound functioned on the hdmi and dp ports.The computer was fully functional.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: 11086905
• MDR Text Key: 225057529
• Report Number: 1723170-2020-03418
• 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
• Report Date: 03/02/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1