MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SEE H10)

Model Number S7

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to (b)(6) patient privacy regulations.No procode, common device name, unique device identification (udi) and/or 510k provided as this device is not released for distribution in the united states.A medtronic representative went to the site to test the equipment.It was reported that the computer of the navigation system was replaced.No parts have been received by the manufacturer for evaluation.

Event Description

A site representative reported that, while in a spinal fusion, the navigation system became unresponsive when powered on.It was reported that restarting the navigation system restored functionality.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

The navigation system's computer was returned to the manufacturer for analysis.Analysis found that it was not possible to duplicate the issue.The computer booted normally to the application screen.There was no unresponsiveness observed during testing.No fault was found.The cause of the reported event could not be determined.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SEE H10)
• 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7338188
• MDR Text Key: 102488201
• Report Number: 1723170-2018-01122
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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