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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 Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
The software investigation found that the reported event was unrelated to a software issue. The software functioned as designed.
 
Manufacturer Narrative
A medtronic representative inspected the navigation system onsite and was able to duplicate the reported issue. When the locking ring was not locked tight and the guide stem was moved after locking the trajectory, the biopsy needle would not navigate. The issue was not the camera or navigation system's ability to 'see' the needle. When the representative tightly locked the ring, the biopsy needle was passed into field of view several times with successful navigation visualization. The passive biopsy needle reflected green on the monitor. It was noted that the biopsy needle is only tracked when it is moving along the trajectory of the plan. If the guide stem is moved to where the biopsy needle is not travelling along the trajectory of the plan, the biopsy needle will not be tracked. No parts were returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while in a cranial biopsy procedure with the navigation system, it was not possible to track the biopsy needle. The biopsy needle was not tracking during a navigus biopsy. The site reset the target and entry of the plan, updated the entry of the plan using the navigus probe, and re-locked the trajectory at least 3 times. The site also tried using another biopsy needle, rebooted the application, re-positioned the camera and was still unable to track the new needle. The site decided to use the suretrak (orange) tracker to track the biopsy needle. There was a reported delay of 45 minutes to the procedure as a result of this issue and no impact on the patient outcome. Pathology confirmed a positive sample was obtained.
 
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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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7110203
MDR Text Key102963749
Report Number1723170-2017-05103
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,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2017
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 Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2013
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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