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

Catalog Number 9735665

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.It was reported that the poe for the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The camera ethernet cable for the navigation system was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The poe for the navigation system was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The poe cable was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The camera of the navigation system was returned to the manufacturer for evaluation.Testing found that the positioning sensor unit (psu) of the camera failed accuracy testing.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A medtronic representative reported that, while outside of a procedure, the navigation system displayed a localizer not connected error message after adjusting the camera arm.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Additional information: device manufacture date and unique device identification (udi) provided.

Manufacturer Narrative

Analysis correction for the camera ethernet cable: poe injector was tested and after 2 hours and 45 minutes led indicator turned from green to red.Re-seating ethernet cables and power did not change led status nor did power cycling the system.Connection cabling/hardware damaged.No power.If information is provided in the future, a supplemental report will be issued.

• 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: dixie wilfong ; 826 coal creek circle; 826 coal creek circle; louisville, CO 80027-9710 ; 9043325313
• MDR Report Key: 7385829
• MDR Text Key: 103970706
• Report Number: 1723170-2018-01406
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• 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
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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