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

Catalog Number 9735665

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.(b)(6).

Event Description

A manufacturer representative reported that, while in a spinal fusion, the navigation system became unresponsive after transferring an image from the medtronic imaging system.It was reported that the site restarted the navigation system without resolution as the exam did not appear on the system.The exam was then manually transferred where the navigation system was then unresponsive for five minutes.The surgeon opted to complete the procedure without the use of the imaging system.The surgeon opted to complete the procedure without the use of the navigation system.There was no reported impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.Medtronic received information that the case was delayed by one hour due to the reported issue.

Manufacturer Narrative

A medtronic representative the logs and loaded the exam.The exam loaded fine with no slow down or hang up.The logs do not show anything related to this unresponsiveness.The representative tried to reproduce this issue by using the same parameters for the imaging system transfer and it worked fine.This issue was documented in a medtronic navigation software anomaly tracking database in order to track monitor for further occurrences.

• 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7392721
• MDR Text Key: 104256254
• Report Number: 1723170-2018-01409
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2018

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: Physician
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 04/05/2018; 04/20/2018
• Supplement Dates FDA Received: 04/19/2018; 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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