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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2018
Event Type  malfunction  
Manufacturer Narrative
The io hub was returned to the manufacturer for analysis. The io hub was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
The medtronic representative reported that after surgery the computer was replaced and the software was installed, however, the issue was not resolved. The pca hub was replaced. The replaced part has not been received by the manufacturer for further analysis. A successful system checkout was performed which verified that the issue had been resolved.
 
Event Description
A medtronic representative reported that during a cranial surgery the camera positioning sensor unit (psu) started to disconnect and reconnect randomly. Even rebooting the steal cranial the camera continued with the disconnection. There was no patient impact and no delay in surgery reported. Surgery proceeded as planned.
 
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Brand NameFUSION NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902447
MDR Report Key7235074
MDR Text Key106855913
Report Number1723170-2018-00511
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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