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

Model Number TREON

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to canadian patient privacy regulations.Device udi not provided as this product is no longer manufactured.A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.

Event Description

Medtronic received information regarding a navigation device, during functional endoscopic sinus surgery (fess).It was reported that the surgeon failed 6 registration attempts prior to cancelling the case.There was a delay of less than 1 hour.Case was rescheduled.There was no known impact to patient outcome.

Manufacturer Narrative

Correction: medtronic received information that the procedure was not cancelled.The archive from the procedure was sent to medtronic for evaluation.It was reported that the forehead of the patient was missing, resulting in the reported issue as there was no portion of the model for registration.

• Brand Name: STEALTHSTATION TREON TREATMENT GUIDANCE 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: 7621992
• MDR Text Key: 111844631
• Report Number: 1723170-2018-02900
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/16/2018

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: TREON
• Device Catalogue Number: 9680111
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2008
• 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