MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) STEALTHSTATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 9660651r, serial/lot #: unknown.No parts have been returned to the manufacturer for analysis.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess) procedure.It was reported that the site was having issues with the axiem box continuously loosing communication.The site was in the register task when it began to lose communication and would turn red in the emitter details.A clinical specialist (cs) was on site to check into the issue and they kept losing communication when in the software.The cs checked, internal and external cables, the number listed on the back was 7, the emitter, and ports.There was a 10 minute delay in the case and no impact on patient outcome.

Manufacturer Narrative

A4: patient weight not available from the site.H3, h6: a medtronic representative went to the site to test the equipment.The axiem box was replaced and the issue was resolved.The system then passed the system checkout and was functioning as expected.Evaluation codes that apply to this testing: 10, 114, 4307.The system 9660651r axiem portable rework (lot# 0200030835) was returned for analysis.Analysis found that the reported problem could not be duplicated.The axiem unit was connected to a test system with the ent application for an overnight burn-in test.Registration, tracking, and accuracy looked normal on all 8 tool ports.The tools were connected / disconnected from each port multiple times and system remained functional.The communication between axiem box and computer functioned normally without failure.Evaluation codes that apply to this testing: 10, 213, 4315.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 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 9470329
• MDR Text Key: 183277865
• Report Number: 3004785967-2019-02144
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 24 YR