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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 Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. A medtronic representative inspected the navigation system onsite and confirmed the surgeon monitor lost power and shut off. The surgeon 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. Functional testing, visual/physical examination could not reproduce the issue. The returned monitor displayed a good image when connected to a known good system. The monitor was allowed to run for an extended amount of time and did not lose the displayed image. No fault was found.
 
Event Description
A medtronic representative reported that while in a procedure the touch surgeon monitor on the navigation system went black. The site reseated the monitor cable within a few minutes and continued. There was no impact on patient outcome reported. No additional information is available.
 
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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
stephanie riley
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7087657
MDR Text Key93889637
Report Number1723170-2017-04793
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2017
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? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2012
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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