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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735665
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
Unique device identification (udi) unavailable. Device manufacturing date is unavailable. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure while the site was setting up for a biopsy that they could not adjust the cone of reachability. The site was using a mouse and the hand icon would not appear. When the site clicked in the box and dragged up and down, the software would zoom in and out with the left and right mouse buttons. Touching the screen would not adjust it either. The site stepped back out of the software and then forward into the software, and then they were able to adjust the cone. No patient was present.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.
 
Manufacturer Narrative
A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined.
 
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Brand NameSTEALTHSTATION S8 PREMIUM SYSTEM
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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7659816
MDR Text Key113261627
Report Number1723170-2018-03086
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
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 Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2018
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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