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

Model Number 9735665

Device Problems Communication or Transmission Problem (2896); Data Problem (3196)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used outside of procedure.It was reported that during inspection of the system, the screw plan and registration plan that were created by the physician were checked.The registration plan did not change from the reading state (it was lefty for about two hours, but the reading state remained).There was no issue with the screw plan.The plans were exported to a usb and then imported.The screw plan could be confirmed but the registration plan disappeared.3d returned to be "stumpy." it was requested that the physician create a new plan.There was no patient present.

Manufacturer Narrative

A workaround method was confirmed to work: "user can re-assign registration points or restart registration to proceed.This issue does not introduce any risk for inaccuracy as a valid registration is needed prior to moving to the navigate task.Any delay will be within expected surgical variation.¿ system service was performed, and no failures were found.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the representative had heard this was a known problem that was being inves tigated.It looked like the issue was not resolved with the software and the issue could not be handled on site.The physician had to hurry and recreate the registration plan before the operation due to this bug, even though the preparation had been performed in advance.It was reported that "registration plan" was referring to the registration points created before surgery in navigation.A back up had been saved to a usb after creating the registration points in case this event occurred.The data that was saved as a backup was imported again.It was noted that the cause was likely sue to a malfunction of the application itself.

Manufacturer Narrative

Additional information was received.Event date has been updated.D11/h2: section d information references the main component of the system.Other relevant device(s) are: product id: 9735737 ; lot #: version 1.2.0.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.

Manufacturer Narrative

H3: the software investigation found that the reported event was related to a software issue.This issue was documented in a software anomaly tracking database.H6: fdm 10, fdr 213, fdc 67.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: 10750426
• MDR Text Key: 213939593
• Report Number: 1723170-2020-02826
• 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,Followup,Followup
• Report Date: 01/29/2021

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
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 11/26/2020; 01/22/2021
• Supplement Dates FDA Received: 11/03/2020; 12/14/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10