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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 EM ENT SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 EM ENT SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735669
Device Problems Mechanical Problem (1384); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 04/28/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: sfw kit 9735736 stealth s8 ent eu-sc. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported by the site that when they load exams onto the system, they all showed up as unknown. The site did not know which patient exam they needed for the next day, so they attempted to reload the disc. After reloading the exam, a database error message appeared on the screen. There was no patient present. Technical services (ts) was able to troubleshoot over the phone with the site. All exams listed as imported since a past date were listed as "unknown" patient name with one exam per patient. The date was set on the system to a specific date. Unknown when that change occurred, or if it was set incorrectly from the start. Date was updated to correct date. Technical services (ts) had the site delete all "unknown" exams that were older than the exam imports for the patients in the upcoming cases. The site then renamed all the "unknown" entries for the upcoming cases, in case they were unable to import. One of the exams would not rename and was deleted, in case it was causing the database problems. The site tried importing again. When exam discs were inserted into the system, the exam list on the "media" screen for the import shows the patient name and mrn. When they are imported, every exam is listed as "transfer failed", but the exams do import completely. However, each exam imports under a different patient entry and all have the name as "unknown". The site said this started happening a few months ago. The site then combined all "unknown" exams from a single exam disc into a new patient entry, then renamed as the actual patient name for use by the site in the upcoming case. The site then moved to the next exam disc and repeated the process. The site stated they will be deleting all older (renamed) exams off of the system when completed.
 
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Brand NameSTEALTHSTATION S8 EM ENT SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key10013148
MDR Text Key189450241
Report Number1723170-2020-01336
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735669
Device Catalogue Number9735669
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 Received04/28/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/19/2018
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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