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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 Problem Imprecision (1307)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 07/02/2018
Event Type  malfunction  
Manufacturer Narrative
Missing udi number. A medtronic representative went to the site to test the equipment. Testing revealed that the system was functioning as intended. The system passed the system checkout and was found to be fully functional.
 
Event Description
Medtronic received information regarding a navigation system during a cranial resection. It was reported that the site registered their patient and verified at known anatomical points and made their burr hole. After this, the surgeon wanted to change his entry point so he put the passive planar on the new entry point and the stealth coordinator at the site tried to make a new entry point but the screen was "flickering around". The surgeon put the passive planar blunt (ppb) down and went to the navigation system. When the surgeon went back and navigated the ppb again, the system was displaying 5cm into the brain. The site switched to the navigus probe and it also showed 5cm deep. The surgery was aborted and rescheduled for next time.
 
Manufacturer Narrative
Additional information: udi and probable cause of issue. Upon communication with on-site representative, it is possible the cause of the issue is related to unintended movement of the reference frame.
 
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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
jack edell
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7710704
MDR Text Key114722872
Report Number1723170-2018-03631
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 08/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2018
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2013
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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