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

Model Number S7

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

Patient Problem No Patient Involvement (2645)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative reported that the computer of the navigation system was replaced to resolve the issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect computer has not been received by the manufacturer for evaluation.

Event Description

A site representative reported that while outside of procedure, the computer of the navigation system was not responding during registration.It was reported that the hard drive was 65 percent free.There was no patient present at the time of the issue.

Manufacturer Narrative

The computer was returned to the manufacturer for analysis.Analysis found that the computer booted normally and no issues with navigating application.Computer passed all tests.No fault found.

• Brand Name: STEALTHSTATION S7 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7427152
• MDR Text Key: 105408687
• Report Number: 1723170-2018-01615
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: 00643169505742
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K050438
• 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
• Report Date: 06/13/2018

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 Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2015
• 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