• 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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial resection procedure. The issue occurred intraoperatively during the navigate task and delayed surgery by 10 minutes. It was reported that the surgeon was unable to put a projection on the passive planar probe in navigation. The surgeon rebooted the system three times and had to re-register all three times with no resolution. The surgeon went to ¿checkpoints¿, then closed the checkpoints, and the select projection button was once again available. The procedure was completed with the use of navigation. No known impact on patient outcome.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated and the issue has not occurred again. The system then passed the system checkout and was found to be fully functional.
 
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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7664001
MDR Text Key113240602
Report Number1723170-2018-03143
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 08/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
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 Received07/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-