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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number I7
Device Problems Imprecision (1307); Device Operates Differently Than Expected (2913)
Patient Problems Tissue Damage (2104); Brain Injury (2219); Iatrogenic Source (2498)
Event Date 12/15/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: a full system check-out was completed and all tests passed. Reported event could not be replicated. Full system functionality was confirmed and the system was returned to service.
 
Manufacturer Narrative
No parts have returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while in a cranial resection procedure an alleged inaccuracy occurred with the navigation system. After registering and checking accuracy, the surgeon felt that they were accurate and continued with a tumor resection. However, following the resection, the surgeon took an imri scan which they merged with the pre-op mr and they saw that the tumor was still visible in the intraoperative magnetic resonance imaging (imri) scan and none of it had been removed. The surgeon then checked the accuracy on the imri and it was accurate. The area resected was reported to be very close to the actual location of the tumor but was at least 5mm off. The site then took a small sample and decided to close and will take an image on a following day. There was a reported delay to the procedure of less than 1 hour due to this issue and the patient was affected as a result.
 
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Brand NameSTEALTHSTATION I7 INTEGRATED NAVIGATION 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
sam saleh
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7180784
MDR Text Key102629594
Report Number1723170-2018-00178
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 02/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberI7
Device Catalogue Number9734060
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/10/2018 Patient Sequence Number: 1
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