MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number I7

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.A manufacturer representative went to the site to test the equipment.The system performed as intended.The navigation system passed the system checkout and was found to be fully functional.Device manufacturing date is unavailable.Part not returned.

Event Description

Medtronic received information regarding a navigation device being used for a procedure.The issue occurred intraoperatively during the register task.It was reported that as the site was getting ready to register, they saw the instruments appeared as "disconnected".The camera appeared as "localizer not connected." site rebooted system and after this the camera started working without issues.There was no impact on patient outcome.Additional information received on a later date reported both the computer and the aiu box were rebooted and the system worked fine.A few registrations were performed to confirm this.

Manufacturer Narrative

Patient weight not available from the site.Additional information: patient information.

Event Description

Medtronic received information regarding a navigation device being used for a tumor resection procedure.The issue occurred intraoperatively during the register task.It was reported that as the site was getting ready to register, they saw the instruments appeared as "disconnected".The camera appeared as "localizer not connected." site rebooted system and after this the camera started working without issues.There was no known impact on patient outcome and no surgical delays.Additional information received on a later date reported both the computer and the aiu box were rebooted and the system worked fine.A few registrations were performed to confirm this.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7633458
• MDR Text Key: 112167298
• Report Number: 1723170-2018-02950
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994653482
• UDI-Public: 00613994653482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I7
• Device Catalogue Number: 9734060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR