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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2019
Event Type  malfunction  
Manufacturer Narrative
Patient weight not available from the site. Other relevant device(s) are: product id: 9735521, serial/lot #: (b)(4), udi#: (b)(4). A medtronic representative went to the site to test the equipment. The manufacturer representative replaced the em controller box. The system then passed the system checkout and was found to be fully functional. The em controller has been received by the manufacturer, however analysis results were not available at the time of filing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a functional endoscopic sinus surgery (fess). It was reported the em controller was intermittent and fluttering between red and green. A manufacturer representative on site was able to confirm the issue was being caused by the panel of the em controller. This issue occurred intraoperatively and caused a one-hour surgical delay. There was no reported impact on patient outcome.
 
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Brand NameSTEALTHSTATION
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 Key9569281
MDR Text Key184346501
Report Number1723170-2020-00095
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,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2019
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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