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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 Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. No parts were replaced in the system.
 
Event Description
Medtronic received information regarding a navigation device being used for a catheter placement procedure. The issue occurred intraoperatively during the navigate task and delayed surgery by less than one hour. It was reported that the site placed 2 catheters at the top of the head with a strata valve. When they went to the left side of the patient posteriorly to place the third catheter, they lost tracking. When they moved the emitter around they were able to track at every location except where the strata valve was. They aborted placing the 3rd catheter as the surgeon decided if they need to place another they can do it on the right side in the future. The surgery was completed with the navigation device and there was no impact on patient outcome.
 
Manufacturer Narrative
A software analysis was initiated. However, the software evaluation found no software anomaly. Per event description, the reported issue was caused by metal interference.
 
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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
koko tyler
navigation customer quality
826 coal creek circle
louisville, CO 80027
7208903200
MDR Report Key7588306
MDR Text Key110657538
Report Number1723170-2018-02674
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 08/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
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 Received08/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2013
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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