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

Model Number 9735665

Device Problems Connection Problem (2900); Device Sensing Problem (2917); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 12/19/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system used during a catheter placement procedure.It was reported that there were issues with the emitter having the localizer faulted message.The surgeon wasn't able to track any instruments at any point.The site swapped the navigation system and the rest of the case went well.2021-dec-20 interface update details (rep) additional information was received.It was reported that the local representative (cc) confirmed she was able to replicate the behavior with the side emitter following the case.She reported the behavior to be intermittent as the localizer status went from red to green when the cable was re-seated but upon reboots the emitter would sometimes be connected and sometimes be faulted.With a known working side emitter, the status of connected remained regardless of reboot and re-seating the cable always resulted in status connected.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735521, serial/lot #: unknown, ubd: unknown, udi#: unknown.No products have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9735521, serial/lot #: unknown, ubd: unknown, udi#: unknown.No products have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system used during a catheter placement procedure.It was reported that there were issues with the emitter having the localizer faulted message.The surgeon wasn't able to track any instruments at any point.The site swapped the navigation system and the rest of the case went well.2021-dec-20 interface update details (rep) additional information was received.It was reported that the local representative (cc) confirmed she was able to replicate the behavior with the side emitter following the case.She reported the behavior to be intermittent as the localizer status went from red to green when the cable was re-seated but upon reboots the emitter would sometimes be connected and sometimes be faulted.With a known working side emitter, the status of connected remained regardless of reboot and re-seating the cable always resulted in status connected.

Manufacturer Narrative

A manufacturer representative went to the site to test the navigation system.The system was performing as intended and hardware parts were replaced.Additional review indicated codes d15, b17, and c20 are no longer applicable to the event.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: analysis found on emitter- analysis determined there was no fault found.B01, c19, d14 applicable codes.Update sn/lot # (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.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• 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: 13056208
• MDR Text Key: 285394973
• Report Number: 1723170-2021-02935
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000272739
• UDI-Public: 00763000272739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 118 KG