• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Imprecision (1307)
Patient Problems Spinal Column Injury (2081); No Consequences Or Impact To Patient (2199); Iatrogenic Source (2498)
Event Date 11/08/2016
Event Type  Injury  
Manufacturer Narrative
On 11/09/2016 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. On 11/29/2016 software analysis was unable to determine probable cause with the information provided. Reported issue could not be replicated. No parts have been received by manufacturer for analysis.
 
Event Description
A site representative reported that, while in a spinal fusion procedure, the surgeon alleged an inaccuracy occurred. No further details regarding this issue, or specifically when it occurred, were provided. No specific measurement, or direction, of the alleged inaccuracy was provided. The surgeon opted to continue and completed the procedure. Delay in therapy was 15 minutes to bring in an alternate navigation system. There was no impact on patient outcome.
 
Manufacturer Narrative
A medtronic representative reported that the surgeon alleged that he was 1mm inaccurate. They finished the procedure using c-arm imaging system. One spine screw was misplaced. The surgeon repositioned the screw under fluoro. There was no negative outcome to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
amos jarrette
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key6142205
MDR Text Key61357691
Report Number1723170-2016-05625
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2010
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: 12/02/2016 Patient Sequence Number: 1
-
-