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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SYSTEM 9733560 FUSION EM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC SYSTEM 9733560 FUSION EM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733560
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: field generator 9731203, em mobile, lot#: unknown, udi#: unknown. The site did not send a purchase order for service, as this was an isolated incident. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system used during a functional endoscopic sinus surgery (fess) procedure. It was reported that the system was intermittently tracking while using the microdebrider and the system would say poor signal. There were no tracking issues with any other instruments. There was no patient impact related to this event. Clarification on the date of the event has been requested.
 
Manufacturer Narrative
Additional information was received. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the case was completed using other instruments and there were no further issues with the navigation system. There was no reported delay to the procedure.
 
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Brand NameSYSTEM 9733560 FUSION EM
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 Key9586579
MDR Text Key175398294
Report Number1723170-2020-00139
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
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 03/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560
Device Catalogue Number9733560
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/21/2016
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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