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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733856
Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. The manufacturer representative (rep) went to the site to test the navigation system. All tests and navigation passed without issues. The hard drive was overloaded and storage was almost at 99% full. They cleared the unused patient files and reduced the memory to 50%. The rep advised the site and users to routinely delete unwanted patient files to free up the memory. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system during an electrode and probe procedure. It was reported that the site uploaded the patient images via usb and when trying to merge acp/mri images, the site couldn't see any images on the screen. The manufacturer representative rebooted the system but the issue was not resolved. The site brought in a second navigation system. The site uploaded the same images via usb and were able to proceed. There was a 20min delay in the case. No impact on patient outcome. Additional information was received stating that the issue was due to an overload on the computer's memory. The manufacturer representative deleted that unnecessary patient files since 2018.
 
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Brand NameSTEALTHSTATION S7 NAVIGATION
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10935235
MDR Text Key219185998
Report Number1723170-2020-03144
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
Type of Report Initial,Followup,Followup
Report Date 06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
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 Received06/15/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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