MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTH AUTOGUIDE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	29631
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Information references the main component of the system.Other relevant device(s) are: product id: 28080, lot/serial #: unknown.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an automated trajectory guidance unit.It was reported outside of a procedure that the control unit connection icon to the stealth was unsteady.No patient was present at the time of the event.Additional information was received stating that the manufacturer representative noticed the issue while checking the connection to the navigation system for a demo.Connection icon to the navigation was unsteady means that the communication with the navigation system was not established successfully.Navigation was not possible to use with the automated trajectory guidance unit.The system was not able to be used.Troubleshooting was not done at the time of the event.At the site the connection was established successfully after several times and after waiting several minutes.Nonetheless the behavior was not normal.
Additional 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 or Problem Description
Additional information was received stating that the issue was resolve by replacing the ssd and the control unit.

• Brand Name: STEALTH AUTOGUIDE SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11552980
• Report Number: 1723170-2021-00759
• Device Sequence Number: 17156111
• Product Code: HAW
• UDI-Device Identifier: 00763000293659
• UDI-Public: 00763000293659
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K191597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 29631
• Device Catalogue Number: 29631
• Device Lot Number: 0070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."