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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 9733560
Device Problems Display or Visual Feedback Problem (1184); 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
Device evaluated by mfr: a medtronic representative went to the site to perform a system checkout. It was reported that the system performed as intended after the computer was replaced. Concomitant medical products: product id: 9735416r, serial/lot#: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from a manufacturer representative regarding a navigation system for a functional endoscopic spinal surgery. It was reported that the software became unresponsive while launching the ent software. They rebooted and it came up normally. In the middle of the case while navigating the screen went black and a reboot resolved the issue. They got stuck in booting after the case. It seemed to be working at the moment.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11097000
MDR Text Key224535048
Report Number1723170-2020-03437
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169504394
UDI-Public00643169504394
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
Report Date 03/10/2021
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 Number9733560
Device Catalogue Number9733560
Device Lot NumberN06753269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
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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