MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON NAVIGATION CART, SHORT; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number TREON SHORT POLE

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date was unavailable.The medtronic representative went to the site to perform a navigation system checkout.The system was not able to be turned on.The system checkout could not be performed.The medtronic representative suspects that the computer had been broken.This facility has another navigation system to use.In the future the medtronic representative will discuss about upgrading this system with the site.No parts were replaced.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported on behalf of a distributor that, while in a spinal fusion procedure, the uninterruptible power supply (ups) of the navigation system seemed to be dead.The system was restored by direct power supply.However, the monitor turned all black during the process.Reportedly, the system was restored by restart, but the surgeon opted to complete the procedure without the use of the navigation system.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

Additional information: device manufacture date provided.Correction: product updated to proper value.

• Brand Name: STEALTHSTATION TREON NAVIGATION CART, SHORT
• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6409574
• MDR Text Key: 70108683
• Report Number: 1723170-2017-01234
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TREON SHORT POLE
• Device Catalogue Number: 9730022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2003
• 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