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

Model Number 9735665

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 9735670 (serial: (b)(6) ); product type: ; implant date n/a; explant date n/a product id (serial: service); product type: ; implant date ; explant date section d references the main component of the system.Other medical products in use during the event include: medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the screen that was connected to the camera (i.E.Camera cart monitor) was shutting down and coming back on after 5 seconds. there was no patient involvement. the field representative (rep) was on site and was unable to replicate the issue despite being on site for 3+ hours. the site confirmed that while in surgery, the system camera cart monitor would go black during navigation (unsure how long in surgery it has been), the main cart display "localizer not connected" and after 5 seconds, the camera cart monitor screen would boot itself into the pcoip screen.This event happened 3 times in total, about 5 minutes apart during surgery.The site was able to complete surgery as intended.No further information available.

Manufacturer Narrative

The following statement should have been populated on the initial regulatory report for this product event instead of the "continuation of d10" that was submitted in the initial regulatory report: continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735788, product id: 9735771, serial/lot #: product id: 9735857.The following statement should have also been included in the initial regulatory report: multiple annex g codes were submitted.Annex g code: g02004 is associated with product id: 9735857, annex g code: g02002 is associated with product id: 9735771, and annex g code: g02027 is associated with product id: 9735788.The following statement should have also been included in the initial regulatory report: no parts have been received by the manufacturer for evaluation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

The system was serviced in the field and the uninterruptible power supply (ups) and batteries were replaced and the system then performed as intended.Codes b01, c02, and d02 are applicable.The product id: 9735788, lot number: 16500379 was returned to the manufacturer for analysis on 2024-04-03.After functional testing and a visual / physical examination, the reported issue was not confirmed.The ups was tested with a known good battery for a 24 hour period and tested with no issues.The ups was then unplugged from alternating current (ac) power and continued to run under battery power for the set 11.5 minutes before the ups shut down as programmed.Codes b01, c19, and d14 are applicable to this returned product analysis.H3, h6) the product id: 9735771, lot number: 1638, was returned to the manufacturer for analysis on 2024-04-03.After functional testing and a visual / physical examination, the reported issue was confirmed.The results concluded that the battery was tested with a known good ups for a 24 hour period.The ups powered down immediately when unplugged from ac power and the battery was found to have low voltage (16.81v) and dead cells.Codes b01, c02, and d02 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18958829
• MDR Text Key: 338468637
• Report Number: 1723170-2024-00876
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2018
• 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 H11...