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

Catalog Number 9735669

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Patient gender was not available from the site.Device udi not provided.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used for functional endoscopic sinus surgery procedure.It was reported that surgeon was seeing an error code 64 when loading patient exams.They rebooted the system and when launching the software they received the error again.They were unable to move forward and navigation was not used in the procedure.On the day of the report, the manufacturing representative was onsite and noted that after reinstalling the application, the exam was able to load, however the system moved into a powered off state and the battery level was at 89%.When they unplugged the system from the wall it shut down immediately.Once the system was plugged back in, they saw the batteries at 89%.On (b)(6) 2018 the rep noted that the ups was installed and the system was charged, but then they unplugged it from the wall, the battery percentage dropped significantly within seconds and was around 30%.There was no patient present when this issue was identified.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.The suspect uninterruptible power supply (ups) was returned to the manufacturer for evaluation.Testing found that the original batteries would not hold a charge and failed load testing.The batteries for the navigation system was returned to the manufacturer for analysis.The batteries was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.

Manufacturer Narrative

Additional information: patient sex received and added.

Manufacturer Narrative

A manufacturer representative went to the site to test the equipment.Testing revealed that the system was not holding a charge when it was not plugged in.Batteries were replaced and the issue was resolved.The system was then holding charge.

• Brand Name: STEALTHSTATION S8 EM ENT 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: 7499123
• MDR Text Key: 107747841
• Report Number: 1723170-2018-01949
• Device Sequence Number: 1
• Product Code: HAW
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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: 67 YR
• Patient Weight: 75