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

Model Number 9735665

Device Problem Imprecision (1307)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6), a medtronic representative visited the site to evaluate the equipment.No failures were found.Codes b01, c19, and d14 are applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used during a brain procedure.It was reported that after registering patient with imaging system and verifying accuracy, the pointer appeared to be in the parenchyma.It was reported that there was a delay to the procedure of 1 hour or longer, and ultimately navigation and surgery were aborted, and the surgery was rescheduled.No other patient impact was reported.Troubleshooting was performed at the time of the event.It was indicated by a nurse that the imaging system had lifted the patient during spin.A new imaging system spin was taken, and had the same inaccuracy.Multiple spins were taken to rule out different possibilities, such as something wrong with the patient or the navigation using an old registration.After surgery was aborted, a local representative did a setup and tested on a resin head.Inaccuracy persisted. it was found that the issue was that the navigate projection had been selected in a previous case and this was not noticed by the local representative during the surgery.User error was confirmed as the cause.There were 5 unused standard spins.

Manufacturer Narrative

H3.Software analysis determined that there was insufficient information to determine root cause of the reported behavior.The case and logs were analyzed.No information captured in logs related to registration accuracy.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: 14375831
• MDR Text Key: 292345331
• Report Number: 1723170-2022-00732
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• 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: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 85 KG