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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 Image Reversal (1358); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2016
Event Type  malfunction  
Manufacturer Narrative
The medtronic representative reviewed localizing images and thumbnails from this patient and they appear to be in the same orientation that they transferred to the navigation system in.It is determined likely that the site radiographic technologist (rt) labeled the incorrect orientation on the imaging system pendant.Recommendations made to the rt for proper protocol regarding correct orientation.Subsequent procedures performed with this system have had no issues, system functioned properly on 10/03/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.No further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a spine sacroiliac joint (sij) procedure, the surgeon alleged the images flipped (r/l and s/i) while using an imaging system navigated spin within synergy spine 2.1 software.The surgeon was confident that the orientation of the imaging system exam did not match the orientation of the exam loaded into the navigation system.The medtronic representative switched the exam orientation on the navigation system.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
 
Manufacturer Narrative
Correction: device manufacture date provided.
 
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Brand Name
STEALTHSTATION S7 SYSTEM
Type of Device
NEUROLOGICAL 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
amos jarrette
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key6062706
MDR Text Key58613139
Report Number1723170-2016-02761
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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 10/03/2016,12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberS7
Device Catalogue Number9733856
Is the Reporter a Health Professional? No
Date Report to Manufacturer10/03/2016
Initial Date Manufacturer Received 10/03/2016
Initial Date FDA Received10/27/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
(B)(4)
Patient Age67 YR
Patient Weight63
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