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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC FUSION ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733560XOM
Device Problems Device Sensing Problem (2917); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 9736119r, serial/lot#: unknown. No parts have been returned 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. It was reported that during a clinical case the site was noticing to have issues with the system becoming unresponsive and loosing its tracking. The site would power the system down and then power it back on. This was noted to happen 2 more times during the case. There was no harm to the patient present. Unknown delay noted.
 
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Brand NameFUSION ENT NAVIGATION SYSTEM
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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key11096444
MDR Text Key224537567
Report Number1723170-2020-03436
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 health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
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 Received01/25/2021
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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