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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 Problems Brain Injury (2219); Therapeutic Response, Decreased (2271); Iatrogenic Source (2498)
Event Date 04/18/2017
Event Type  Injury  
Manufacturer Narrative
The site declined to provide patient information, per (b)(6) privacy laws. No parts have been received by manufacturer for analysis.
 
Event Description
A medtronic representative received a report from a site that while in a cranial tumor biopsy procedure, their navigation system was unable to track the biopsy needle. In trouble-shooting, the navigation system was turned off, a second biopsy needle was used and they were still unable to track properly. Navigation was abandoned and they proceeded with open craniotomy. Delay in therapy was less than one hour. The surgeon completed the procedure without the use of the navigation system.
 
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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
judith ericson
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6563195
MDR Text Key75036988
Report Number1723170-2017-01990
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
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 Received04/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2013
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: 05/12/2017 Patient Sequence Number: 1
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