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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2018
Event Type  malfunction  
Manufacturer Narrative
Udi not available for this system at time of filing. Device manufacturing date is unavailable at this time. A medtronic representative inspected the navigation system onsite and confirmed the surgeon monitor was not working and would not turn on at all. The monitor was replaced and the issue resolved. A full system check-out was completed following part replacement and all tests passed. Full system functionality was confirmed and the system was returned to service. The suspect monitor was returned to the manufacturer for evaluation and the issue was confirmed. The monitor had a blank display when connected to a known good system.
 
Event Description
A medtronic representative reported that while in a stem cell injection procedure, the surgeon monitor went black on the navigation system in between planning and navigating. The site swapped out the impacted surgeon monitor with another one and the system worked as intended. There was a reported delay to the procedure of less than 1 hour due to this issue and no impact on the patient outcome.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.
 
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Brand NameSTEALTHSTATION S7 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
7635267745
MDR Report Key7298869
MDR Text Key101018070
Report Number1723170-2018-00886
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2011
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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