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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC FUSION® ENT NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733560
Device Problems Environmental Compatibility Problem (2929); Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: 9736119. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that the system was frequently freezing. A restart was done automatically. The procedure was delayed by less than one hour. There was no impact on patient outcome.
 
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Brand NameFUSION® ENT NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13002619
MDR Text Key288607519
Report Number1723170-2021-02883
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 Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
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? Yes
Date Manufacturer Received05/10/2022
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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