MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7¿; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9733856

Device Problems Connection Problem (2900); Environmental Compatibility Problem (2929); Material Integrity Problem (2978); Temperature Problem (3022); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9660651r.Product id: 9731203.H3, h6: a medtronic representative went to the site to test the equipment.Testing revealed that the emitter was not functional.The navigation system then passed the system checkout and was found to be fully functional.B01, c13, d02 are applicable.H3, h6: no parts have been returned to medtronic for analysis.B17, c20, d15 are applicable.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 information regarding a navigation device being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that this system's electromagnetic emitter would not connect to the navigation system.The manufacturer representative attempted to reseat the emitter and reboot the system, but the issue persisted.The manufacturer representative was unable to perform further troubleshooting. the manufacturer representative reported that when in an ent procedure, the electromagnetic navigation interface unit (axiem box) kept flickering red for a split second, every second.The reason the emitter was not communicating with the axiem box was because the connection between the axiem box and the navigation system was intermittent.The manufacturer representative opened the axiem box to find that the controller connection was as intermittent as the app ui screen.The power and temp portions of the window did not show okay for the controller.The manufacturer representative opened the system and plugged the axiem power into a different port on the uninterruptible power supply (ups), but that did not resolve the issue either.This occurred preoperatively, and there a surgical delay of less than one hour.There was no reported impact to patient outcome.

Manufacturer Narrative

H3: the system was serviced in the field, and hardware parts were replaced.Codes b01, c13, d02 are applicable.D9, h2, h3: the return of 9660651 provided the lot number 0200057339.The hardware was returned and analysis was performed.The axiem unit was connected to a test system with the ent application.Registration, and tracking, looked normal on all 8 tool ports.The system remained functional with no failures.Codes b01, c19, d14 are applicable to this analysis.The return of 9731203 provided the lot number 0400007690.The hardware was returned and analysis was performed.The inside of the emitters lemo connector to the axiem box, many of the prongs were bent and was unable to fully insert the connector in to the axiem box.Codes b01, c07, d02 are applicable to this analysis.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® S7¿
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17350516
• MDR Text Key: 319715471
• Report Number: 1723170-2023-01277
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10...
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 82 KG