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

Model Number S7

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); Brain Injury (2219); Iatrogenic Source (2498)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

In trouble-shooting, the medtronic representative reviewed the exam archive and found that the surgeon was using a cta with a large field of view (fov) that included the sternum. The tracer appeared shifted laterally, since there were no points shown collected on the nose, only points showing next to the nose along the cheek. It is suspected the initial blue dots appeared shifted as well and were not corrected and accuracy was not confirmed following tracer. - return requested. No parts have been received by manufacturer for analysis. - on 04/19/2017 a medtronic representative performed a navigation system check-out. Hardware and instruments testing passed. - on 05/02/2017 software investigation completed. Findings are that analysis of patient logs shows the patient exam was not to protocol and tracer pattern was not adequate. Software is functioning as designed. - medtronic representative reported the site has received additional training in proper protocol for patient exam and tracing patterns.

Event Description

The physician in the case reported that while in a cranial biopsy procedure with the navigation system was inaccurate. A sample was taken, and sent for testing. However, when the biopsy was reviewed, it was healthy brain tissue. There was no delay to the case and the patient is scheduled for revision surgery with another navigation system on (b)(6) 2017. A medtronic representative reported that while in a cranial biopsy procedure the surgeon alleged an inaccuracy occurred. No specific measurement, or direction, of the alleged inaccuracy was provided. A sample was taken, and sent for testing, however, when the biopsy was reviewed, it was found to be healthy brain tissue. There was no delay to the case and the patient is scheduled for revision surgery with another navigation system on (b)(6) 2017.

Manufacturer Narrative

Correction: to the fda results and conclusion codes. As reported on initial mdr, software was functioning as designed. Patient exam was not to protocol and tracer pattern was not adequate.

• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7633987612
• MDR Report Key: 6567600
• MDR Text Key: 75181142
• Report Number: 1723170-2017-01784
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 05/15/2017 Patient Sequence Number: 1