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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 Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 01/08/2016
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2016 a medtronic representative, following-up at the site, reported the alleged inaccuracy was reported to have been 2-3 millimeters off. On (b)(6) 2016 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. On (b)(6) 2016 software analysis was unable to determine probable cause with the information provided. The medtronic representative noted that they were shifting the anatomy in an attempt to redirect a tap that was already engaged, therefore, making their approach look correct when it may actually not have been what they desired. It is suspected that the frame to patient relationship changed which may have invalidated the registration. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a spine procedure, using a navigation system and an imaging system, the surgeon deemed the three screws were misplaced and alleged an inaccuracy. No specific measurement was given for the alleged inaccuracy. The surgeon has a unique approach that he has developed to place bilateral 'claw screws'. One of the screws went through t3 into t2 and another of the surgeon's pedicle screws felt inaccurate at t6. Screws were placed from t2 to the pelvis. Accuracy was checked periodically throughout the procedure by putting a navigated instrument on known anatomy, this was done without difficulty. Screws were re-directed using fluoroscopy without issue, or any known patient complication, and the procedure proceeded as planned. The medtronic representative noted that they were shifting the anatomy in an attempt to re-direct a tap that was already engaged, therefore, making their approach look correct when it may actually not have been what they desired. The surgeon completed the procedure with the use of the navigation system. Delay in therapy was less than one hour.
 
Manufacturer Narrative
The instructions for use, which accompany this device, states: "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. ".
 
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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
kristianna bilan
826 coal creek circle
louisville, CO 80027-9710
7208902338
MDR Report Key5397451
MDR Text Key37085570
Report Number1723170-2016-00127
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 03/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2016
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 Received02/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2014
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: 01/28/2016 Patient Sequence Number: 1
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