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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 Patient Involvement (2645)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have returned to the manufacturer for evaluation.No parts have returned to the manufacturer.
 
Event Description
A site representative reported that, while outside of a procedure, there was a defect in the navigation systems surgeon monitor.After connection, the monitor starts, but stops functioning after a few seconds.There was no patient present when this issue was identified.
 
Manufacturer Narrative
Additional information: medtronic received information that the site purchased a new monitor for the navigation system.However, the site did not provide confirmation for medtronic to test the navigation system following replacement nor conduct the replacement.
 
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Brand Name
STEALTHSTATION S7 SYSTEM
Type of Device
NEUROLOGICAL 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 Key7123133
MDR Text Key95071184
Report Number1723170-2017-05167
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450968
UDI-Public00613994450968
Combination Product (y/n)N
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberS7
Device Catalogue Number9733858
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2017
Initial Date FDA Received12/15/2017
Supplement Dates Manufacturer Received08/22/2018
Supplement Dates FDA Received08/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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