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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 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information was not made available from the site. On 11/09/2016, a medtronic representative performed a navigation system check-out. Reported issue could not be replicated. System performed as intended. Conducted investigation with the site operating room (or) team and they are sure that the surgeon has accidentally moved the reference frame. Determined this to be a user error. No further issues have been reported.
 
Event Description
A site physician alleged that, while in a spinal fusion procedure, an inaccuracy occurred. This was a minimal invasive procedure. Reference was placed on the iliac crest. Pak needle navigation was on l2, on the navigation system surgeon monitor, the pak needle blue representation suddenly moved more lateral, approximately 2 centimeters, for no apparent reason. The surgeon opted to continue and completed the procedure with the use of the navigation system. Delay in therapy was less than one hour. There was no impact on patient outcome.
 
Manufacturer Narrative
Patient information now provided. The instructions for use (ifu) which accompanies this device contains the following warnings regarding frame movement: "warning: make sure that the reference frame assembly is rigidly attached and locked (tightened) with respect to the relevant anatomy. If the post or clamp moves in relation to the anatomy, navigational inaccuracy may result. " and "warning: do not bump or reposition the reference frame after registration. Such movement may result in inaccurate navigation. If the reference frame moves in relation to the patient anatomy at any time after registration, you must reregister. ".
 
Manufacturer Narrative
The suspect device was returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
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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
7208902338
MDR Report Key6138020
MDR Text Key61245362
Report Number1723170-2016-05613
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450968
UDI-Public00613994450968
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2013
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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