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

Catalog Number 9735665

Device Problems Imprecision (1307); Device Displays Incorrect Message (2591)

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

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been returned to the manufacturer for evaluation.Udi and manufacture date not available for this system at time of filing.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The issue occurred intraoperatively during the register task and delayed the surgery by 40 minutes.It was reported that the surgeon was unable to accurately register.They got a good error metric of around 2.5mm but were a few centimeters off when verifying accuracy.A manufacturer representative (mr) saw that the exam has the back portion of the 3d model cut off.The site reported that they had used other scans without it cut off and had the same issues.The mr watched the site register and as the surgeon was tracing the nose the tracer pattern was on top of the patient¿s skull.The trace oriented correctly, and they got a 2.3mm error metric, but they were still inaccurate.Adding points did not improve they still were inaccurate.The surgery was completed without navigation and there was no impact on patient outcome.

Manufacturer Narrative

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

Manufacturer Narrative

Correction: when the representative visited the site surgeon reported that the site had loaded a wrong exam and the patient did not have large bump on their head.Accuracy was good with the mri scan but surgeon needed ct for the tumor approach.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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7687227
• MDR Text Key: 114016578
• Report Number: 1723170-2018-03412
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 78