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

Model Number S7

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

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

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Patient gender, date of birth, ethnicity and race were unavailable from the site.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used for a spinal fusion procedure.It was reported that the site was preparing for navigation.The imaging system's 3d scan transmitted to system then the software showed the message "exiting" and froze.They restarted the system and the issue reoccurred.On site, there was a reinstall of the spine software and deletion of the last patient,which may have produced the error.This did not resolve the issue.An error message indicating a failure to read the file was displayed.Medtronic navigation was aborted.The patient impact related to the event was not clear at the time of the report.There was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

Additional information: there was no impact on patient outcome.The surgeon opted to complete the procedure without the use of the imaging system.The surgeon opted to complete the procedure without the use of the navigation system.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the issue could not be replicated.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7654152
• MDR Text Key: 112845153
• Report Number: 1723170-2018-03050
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: 00643169505742
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 11/20/2018

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: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 08/20/2018; 08/20/2018
• Supplement Dates FDA Received: 08/30/2018; 11/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2015
• 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: 60 YR
• Patient Weight: 70