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

Model Number S7

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.It was reported that the camera and monitor of the navigation system were replaced to resolve the reported issue.

Event Description

A medtronic representative reported that, while outside of a procedure, the camera of the navigation system displayed a bump.It was noted that the amber led on the camera was illuminated.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Correction: system information updated to proper value.Additional information: manufacture date provided in appropriate field.

• 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
• MDR Report Key: 7318281
• MDR Text Key: 101715989
• Report Number: 1723170-2018-01020
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/11/2018
• Supplement Dates FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• 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