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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 No Display/Image (1183)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. Unique device identifier (udi) is unavailable. Device manufacture date is unavailable. A medtronic representative went to the site to test the equipment. The representative was unable to replicate the reported issue. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Event Description
A manufacturer representative reported that, while setting up for a spinal fusion, the monitor of the navigation system lost display functionality. It was noted that the second monitor operated as designed. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact on patient outcome. No additional information was provided.
 
Manufacturer Narrative
Correction: fdp updated to proper value.
 
Manufacturer Narrative
Additional information: device manufacture date and unique device identification (udi) provided.
 
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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 Key7363195
MDR Text Key103269959
Report Number1723170-2018-01240
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
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 Received03/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2017
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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