• 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 Erratic or Intermittent Display (1182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. Onsite functional and visual examination was performed by a manufacturer representative. The computer, and vga splitter were replaced was replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition.
 
Event Description
Medtronic received information regarding a navigation device being used for a catheter-based procedure. It was reported that the screen went fuzzy and the system shut down three times during planning. A manufacturer representative tried to replicate the issue on the phone with the site, but the system booted and loaded images fine twice. Use of the navigation and imaging systems was aborted. The procedure was completed and there was no reported impact to the patient. Surgical time was extended by less than one hour.
 
Manufacturer Narrative
The video splitter was returned to the manufacturer for analysis. Analysis found that the video splitter displayed a good image for each output. No problem was found. The computer was returned to the manufacturer for analysis. Analysis could not replicate the reported issue; no fuzzy screens or automatic shutdowns were observed during testing. However, analysis found that the computer froze while starting the ent application. The software was running slow in the select procedure screen. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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
parker desautel
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7872832
MDR Text Key120154988
Report Number1723170-2018-04627
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-