MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735665

Device Problem No Display/Image (1183)

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

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that after an imaging spin trajectory 1 view was not available, re-pushing the last imaging spins images to navigation system and trajectory 1 images were visible and accurate.The system then passed the system checkout and was found to be fully functional.

Event Description

Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively during the navigate task and delayed the surgery by less than one hour.It was reported that during an imaging device case, after an imaging spine completion the trajectory 1 view was showing a blank screen.The trajectory 2 view would show the anatomy and instrument model.After re-pushing the last imaging spin to navigation system , images for trajectory 1 were visible and accurate.The surgery was completed with navigation and there was no known impact on patient outcome.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.

Manufacturer Narrative

Correction: report source: foreign.

Manufacturer Narrative

Additional information: device manufacture date provided.Correction: sequence number mdrs 2 and 3 inadvertently filed.Should have been filed under mdr 1723170-2017-03450 not mdr 1723170-2018-03450.

Manufacturer Narrative

Software investigation was initiated to determine probable cause.Per engineering review, logs and case details were reviewed but provided no additional insight into the cause.The software investigation was unable to determine probable cause of the issue without further information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: information submitted on manufacturer report # 1723170-2018-03450 follow-up numbers 1 and 2 do not pertain to this event.They pertain to the event detailed in manufacturer report # 1723170-2017-03450.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7546007
• MDR Text Key: 114046050
• Report Number: 1723170-2018-03450
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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 Age: 61 YR
• Patient Weight: 77