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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON NAVIGATION CART, SHORT NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameSTEALTHSTATION TREON NAVIGATION CART, SHORT
Type of DeviceNEUROLOGICAL 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 Key6409574
MDR Text Key70108683
Report Number1723170-2017-01234
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTREON SHORT POLE
Device Catalogue Number9730022
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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