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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 Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
Information received about patient demographics. A software investigation analysis was initiated to determined the probably cause of the issue through reproducibility. Analysis found that the cause of the event was user error and that the software functioned as designed. A medtronic representative went to the site to test the equipment. Testing revealed that after registration, the reference frame was moved which caused the issue. Otherwise system operated as intended.
 
Manufacturer Narrative
Patient information was unavailable from the site. No parts have been received by the manufacturer for evaluation. The instructions for use (ifu) that accompanies the device contains warnings regarding patient reference movement: "warning: do not bump or reposition the patient reference after registration. Movement of the patient reference will result in inaccurate navigation. If the patient reference moves in relation to the patient anatomy at any time after registration, you must re-register. ".
 
Event Description
A site representative reported that after they registered they were inaccurate about 4 mm inferior during a cranial resection procedure. The surgeon attempted to move the reference frame and obtain better accuracy. Surgeon requested the reference frame arm to be loosened and re-position the frame. A medtronic representative advised that this was not a method that was advised or that we could verify. The surgeon checked bony landmarks under the skin and felt that it was "ok" and accuracy was "better than it was. " a medtronic representative again advised against it, however the surgeon opted to proceed with the surgery. The delay was reported to be less than one hour. The procedure was completed with the navigation system. There was no reported impact to the outcome of the patient.
 
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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
stephanie riley
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7156331
MDR Text Key119070604
Report Number1723170-2017-05359
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 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2010
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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