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

Model Number S7

Device Problems Computer Software Problem (1112); Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative inspected the navigation system on-site, and a software investigation was completed.On-site, it was found that instruments verify, resin head registers, and two accurate optical cases have been completed since the reported event.The issue could not be replicated.The software investigation found that a ct and mr were merged together and the mr was chosen as the reference exam.This mr was missing the ears and the model was less-than-ideal quality.The registration (tracer) pattern could've been improved as well.The software was determined to be functioning as designed.Poor exam quality and registration technique were determined to be the root cause of the reported inaccuracy.A full navigation system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that during a craniotomy procedure, the surgeon felt inaccurate while using the navigation system.Details as to the magnitude and direction of the inaccuracy were not provided.The procedure was completed successfully with the use of the navigation system, and the patient was not impacted.No further details were provided.

Manufacturer Narrative

A medtronic representative, following up with the site, reported that the inaccuracy was noted after registration, during navigation, the procedure was completed with the surgeon accounting for the inaccuracy and with the use of the navigation system.The delay to the procedure was reported as nominal.The instructions for use (ifu) which accompanies this device contains guidance and instructions regarding proper imaging protocols.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6125811
• MDR Text Key: 60878659
• Report Number: 1723170-2016-05530
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/21/2016

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: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2013
• 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