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

Model Number S7

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

No procode, common device name and/or 510k provided as this device is not released for distribution in the united states.

Manufacturer Narrative

The computer for the navigation system returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

Patient information not provided due to japanese patient privacy regulations. The software investigation found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database.

Event Description

A site representative reported that during a procedure, the navigation system unexpectedly rebooted without any prompt form user and upon booting up a "no signal" was displayed. Rebooting the system multiple times resolved the issue and the site proceeded with procedure. The procedure was completed with the use of navigation. There was no delay to procedure. No impact on patient outcome.

• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7146324
• MDR Text Key: 103050777
• Report Number: 1723170-2017-05297
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: S7
• Device Catalogue Number: 9734056
• 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: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse