• 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 Problems No Display/Image (1183); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Patient Involvement (2645)
Event Date 08/02/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. Testing revealed that the cpu would not boot.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that during the installation of the replacement central processing unit (cpu), the software kept hanging when exiting from the cranial app and admin to login screen. The system had to be manually powered off and on to login to the cranial app. After 7 cycles of hard reboot, no signal input was displayed on the staff and surgeon monitor. There was no video output from the cou. The cpu fan turned on and off. There was no patient present when this issue was identified.
 
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
maxwell roth
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7820547
MDR Text Key118393593
Report Number1723170-2018-04270
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450968
UDI-Public00613994450968
Combination Product (y/n)N
Reporter Country CodeSG
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-