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

Model Number S7

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative. The network cable on the i/o panel failing to receive exams. The network port was replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: supplemental report 001 of this occurrence inadvertently filed. Information filed under 1723170-2019-01509. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a software investigation analysis was initiated to determine the probable cause of the issue through log analysis. Analysis found that the analysis was inconclusive and probable cause was unable to be determined. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient weight not available from the site. A medtronic representative inspected the navigation system onsite and found that after taking the imaging system spin and in the spine software, the x-ray images were black on the navigate screen on the staff cart, but they showed up on the surgeon monitor. After rebooting the navigation system it was possible to send over the same exam and see the x-ray images again on the staff monitor. No parts were replaced or returned to the manufacturer for evaluation.

Event Description

A medtronic representative reported that while in a sacroiliac and thoracolumbar procedure, there was an image transfer issue with the navigation system. The images that were sent over from the imaging system showed up on the staff cart monitor black. The images showed up fine on the staff cart monitor and other monitors in the operating room (or). There was no delay to the case as a result of this issue and no impact on the patient outcome. After the case, the system was rebooted and it was possible to see the patient images.

• 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: stephanie riley ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7184157
• MDR Text Key: 131810681
• Report Number: 1723170-2018-00197
• 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

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse