• 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); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/06/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative inspected the navigation system onsite and confirmed that there was no signal going to the surgeon monitor. Additionally, the uninterruptible power supply (ups) was not functioning when the system was unplugged. The power supply was replaced and the issue resolved. The representative also replaced the uninterruptible power supply (ups) and ups batteries. A full system check-out was completed following part replacement and all tests passed. Full system functionality was confirmed and the system was returned to service. No parts have returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while outside of a procedure, the surgeon monitor on the navigation system was not getting power. The representative tested the output on the multi-out power supply and was not getting any voltage back form the monitor input. There was no patient present when this issue was observed.
 
Manufacturer Narrative
The uninterruptible power supply (ups) was returned to the manufacturer for evaluation. When attached to a known operational battery, the ups would power down immediately. It was noted that all outputs measure normally once the ac was disconnected. The power supply of the imaging system was returned to the manufacturer for evaluation. Testing found that there was a fuse that was open on the board of the power supply.
 
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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7307936
MDR Text Key101348974
Report Number1723170-2018-00962
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-