• 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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
Event Type  malfunction  
Manufacturer Narrative
Unique device identification(udi) is not available. Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. Testing revealed that the computer was replaced. The system then passed the system checkout and was found to be fully functional. The computer was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Event Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure. The issue occurred intraoperatively during the register task and delayed surgery by less than one hour. It was reported that after registration the screen went blank then blue. The site shut down the system and completed the surgery without navigation. There was no known impact on patient outcome.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided. Correction: product and related fields updated to proper value. A software analysis was initiated to determine the probable cause of the issue through known anomaly determination. Analysis found that the reported event was related to a software issue. This issue was documented in a medtronic navigation software anomaly tracking database.
 
Manufacturer Narrative
Correction: product information noted in supplemental report 1 was not included.
 
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
stephanie riley
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7638439
MDR Text Key112363660
Report Number1723170-2018-02998
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,Followup
Report Date 07/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733927
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-