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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735602
Device Problem Communication or Transmission Problem (2896)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2020
Event Type  malfunction  
Manufacturer Narrative
No products have been returned to medtronic for analysis. 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 images, once downloaded, had inverted color. The local representative (cs) was able to adjust the settings and then re-download the images and they came in perfectly. There was a delay to the procedure of less than one hour. There was no reported impact to the patient.
 
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Brand NameFUSION COMPACT
Type of DeviceEAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10471358
MDR Text Key204937330
Report Number1723170-2020-02317
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153247
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 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735602
Device Catalogue Number9735602
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 Received11/17/2020
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 Reuse

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