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

Catalog Number 9735665

Device Problems Device Stops Intermittently (1599); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.The representative reported that there were no issues found with the navigation system.It was noted that the left tracker on the imaging system was not being observed while the right tracker functioned as designed.The tracker was then replaced on the imaging system, as reported in mdr 1723170-2017-05224.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced, therefore no parts were returned for analysis.

Event Description

A medtronic representative reported that, while outside of a procedure, the navigation system was intermittently unable to communicate with trackers on the medtronic imaging system.It was reported that the right side trackers were intermittently tracking while the left side were difficult to establish communication with, but not intermittent.It was reported that the navigation system camera was moved without resolution.A second medtronic navigation system was reported to not have issues tracking the imaging system.There was no patient present when this issue was identified.No additional information was provided.

• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7133605
• MDR Text Key: 95473270
• Report Number: 1723170-2017-05223
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• 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
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2017
• 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