MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734061
Medical Device Problem Codes	Material Integrity Problem (2978); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: unk_nav_comp, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the camera was not turning on.The camera was not working when the system was turned on.No lights were on the camera, and the status said, "localizer is not connected".No patient was involved.The next action was to replace the localizer.
Additional Manufacturer Narrative
H3: the manufacturer representative went to the site to test the navigation system.The camera was off and the localizer was not con nected.They reset the polaris spectra system control unit (scu) and the general failure was resolved.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
Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: 9734165, lot/serial #: (b)(6); product id: 9734979, lot/serial #: (b)(6); product id: 9734059, lot/serial #: (b)(6); product id: 9734058, lot/serial #: (b)(6).H3) the transceiver was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The transceiver was tested with other returned components and was found to not display image from any of the three ports.Internal dvi splitter led was on but no image was displayed.Power remained red, normally it would be blue, and usb light remained off.Normally it would be green.B01, c02, d02 another transceiver was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The transceiver looks to be unused (rubber feet still present) and functions as expected.B01, c19, d14 the polaris spectra system control unit (scu) cable was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The cable was tested and found to provide power to the camera, functions as expected.B01, c19, d14 the extension cable was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.Cable seems to be unused, testing did not find any opens or shorts.B01, c19, d14.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 I7 INTEGRATED NAVIGATION SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11848242
• Report Number: 1723170-2021-01334
• Device Sequence Number: 19811005
• Product Code: HAW
• UDI-Device Identifier: 00613994667458
• UDI-Public: 00613994667458
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 08/23/2021

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: 9734061
• Device Catalogue Number: 9734061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 08/16/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/01/2021; 08/23/2021
• 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...."