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

Model Number S7

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

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.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.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A medtronic representative reported that, while outside of a procedure, the positioning sensor unit (psu) for the navigation system powered down without prompt from the user.It was noted that the amber led on the camera was illuminated.Without prompt from the user, the issue was resolved with time.The reported issue could then not be reproduced after restarting the navigation system.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Additional information: manufacture date is now provided in appropriate field.

• 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: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7175097
• MDR Text Key: 96832347
• Report Number: 1723170-2018-00118
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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