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

Model Number	9735667
Medical Device Problem Codes	Connection Problem (2900); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Concomitant medical products: product id: 9735737, serial/lot #: (b)(4).The manufacturer representative went to the site to test the navigation system.The system was performing as intended and no parts were replaced.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported outside of a procedure that when the system was plugged in yesterday evening the amber light on the camera was on and the software read " localizer not connected".The umbilical was reseated and the system was reboot without resolution.The system was shut down for the night and the issue was resolved on boot up the next morning.The system appears to be functional right now.No patient was present at the time of the event.Additional information was received stating that the manufacturer representative (rep) requested that the logs be read immediately to see if the camera needed the be replaced.The rep confirmed that the system was working as intended.The call dropped and an email was sent recommending how to check the ndi toolbox to see if any faults were listed.If not, the error was recovered and camera will not need to be replaced.The rep sent in the ndi toolbox picture and no faults were listed after the initial call and reboot.The system checkout had the system working as intended.No need to replace the camera.
Additional Manufacturer Narrative
H3: a medtronic representative went to the site to test the equipment.Testing revealed that the red led on the camera was powered on.To restore functionality, the camera and power pack were replaced.The system then passed the system checkout and was found to be fully functional.Continuation of d10: pn: 9735821, ln/sn: (b)(6).Pn: 9735821, ln/sn: (b)(6) 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.
Additional Manufacturer Narrative
The positioning sensor unit (psu) for the navigation system was returned to the manufacturer for evaluation.Testing found that the event logs showed an intermittent history of firmware incompatibility.Additionally, the psy was noted to have failed accuracy testing.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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.
Additional Manufacturer Narrative
H3) the software team investigated the reported issue and based on the information provided, software seems to be working as designed.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.
Additional Manufacturer Narrative
H3: the camera base was sent to the vendor for further analysis.The fault description was confirmed.Vega log file indicate a history of the fault "firmware incompatibility." the occurrence of this fault is a result of a known minor bug in the firmware revision of this vega.This minor bug has been corrected in recent firmware revisions.The returned unit was characterized as extended pyramid volume.Unit also passed outgoing product testing.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
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11055167
• Report Number: 1723170-2020-03368
• Device Sequence Number: 2636185
• Product Code: HAW
• UDI-Device Identifier: 00643169876972
• UDI-Public: 00643169876972
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735667
• Device Catalogue Number: 9735667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/29/2020; 02/10/2021; 03/17/2021; 04/30/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/20/2021; 02/17/2021; 03/18/2021; 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1