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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC FUSION 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 04/15/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9731203, serial/lot #: unknown. 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) procedure. It was reported that although the system was at a state that there was no interference, it would not react unless the emitter was brought close to it. The procedure was able to be completed using the navigation system. There was a less than 1 hour delay and no impact to patient outcome as a result of this issue. The system type was reported to be a fusion system. Issue has not been resolved yet. It will be replaced with a new one, but it has not been decided due to the influence of corona. Although the cause of the issue has not been determined yet however, it seems to be the emitter.
 
Manufacturer Narrative
The model number and brand name of the system has been updated in section d. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameFUSION
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 Key10017933
MDR Text Key189620275
Report Number1723170-2020-01355
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2020
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 Unkown

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