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

Model Number S7

Device Problem Poor Quality Image (1408)

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

Event Date 06/24/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier could not be obtained.A medtronic representative went to the site to test the equipment.Testing revealed that the system was functioning as intended.The system then passed the system checkout and was found to be fully functional.No parts were returned for analysis.Device manufacturing date was unavailable.

Event Description

Medtronic received information regarding a navigation device being used for a cranial resection procedure.It was reported that when the microscope was connected with the system, but not when the two were disconnected, there was a ¿dark area¿.There were a lot of very little white dots in the area, like some kind of snow artifact.But if the microscope didn¿t connect with navigation, there were no such dots in that area.There was no patient impact reported.

Manufacturer Narrative

Additional information: manufacture date provided.Correction: unique device identification(udi) updated to proper value.

Manufacturer Narrative

Medtronic received information that the troubleshooting did not restore functionality to the navigation system.It was reported that the scope screen for the microscope was displayed without proper display functionality.It was reported that the computer of the navigation system was replaced without resolution.The display would restore functionality when selecting the proper procedure, but following an exit from the application software, the display would not work.

Manufacturer Narrative

Additional information: medtronic received information that the external microscope communication cable was replaced without resolution.

Manufacturer Narrative

Software analysis was performed.The cause of the issue was unable to be determined.If information is provided in the future, a supplemental report will be issued.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7695036
• MDR Text Key: 114294730
• Report Number: 1723170-2018-03511
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450951
• UDI-Public: 00613994450951
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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,Followup,Followup,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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: 58 YR
• Patient Weight: 62