• 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 No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 04/25/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Udi not available for this system at time of filing. Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. The representative replaced the digital visual interface (dvi) cable. The navigation system then passed the system checkout and was found to be fully functional. The suspect digital visual interface (dvi) cable was returned for analysis. The cable was found to be in good condition with no faults found.
 
Event Description
Medtronic received information regarding a navigation device. It was reported that the navigation system was showing no signal on both monitors. When the cables were reseated into the back of the computer, the issue resolved. The issue was reported to be intermittent and only resolved when the cable was seated back into the computer. No complications were reported/anticipated.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided.
 
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
heather davis
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7534174
MDR Text Key108985102
Report Number1723170-2018-02198
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-