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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 9733856
Device Problems Human-Device Interface Problem (2949); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9731203. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that, while in a functional endoscopic sinus surgery (fess), the navigation system was intermittently tracking instruments. It was also reported that the patient tracker location would move in the application software without prompt from the user. It was reported that the site was able to pass patient registration and navigate after three registration attempts. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact on patient outcome. After the procedure, it was noted that there was damage on the emitter that restricted the navigation field on the right side.
 
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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 Key9439959
MDR Text Key183132534
Report Number1723170-2019-05919
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
Report Date 12/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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