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

Model Number 9735665

Device Problems Human-Device Interface Problem (2949); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that a 3d tumor model off an exam was unable to be built.When attempting to build model there was also an error message of "warning: low system memory" appeared and was unable to complete the model.For troubleshooting, thefile sizes were checked for lag, all but relevant patient information was removed.The model was switched to building base, the memory usage and the kib swap in the terminal window was looked at.The resolution was unable to be determined.There was no patient involvement.

Manufacturer Narrative

Continuation of concomitant medical products: suspect medical device information references the main component of the system.Other relevant device(s) are: product id: 9735737, software version: 2.0.1.Device evaluated by mfr: a software investigation analysis was initiated to determine the probable cause of the issue through log and archive analysis.Analysis found that the archive had 1 computer tomography <(>&<)> 2 magnetic resonance exams.Dicom directory was 796mb.Building the registration model took more than 15 seconds when loaded on the archive in house.¿low memory¿ could not be observed in registration or navigation tasks.One application was present in the log folder.Logs reported many ¿low memory¿ errors during build model and registrations tasks.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.B01, c10, d02 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.

• 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: 16300912
• MDR Text Key: 308845526
• Report Number: 1723170-2023-00159
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• 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: 10/31/2022
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2020
• 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