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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) AWL/PROBE/TAP DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) AWL/PROBE/TAP DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number APT DRIVER
Device Problems Unstable (1667); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2016
Event Type  malfunction  
Manufacturer Narrative
Device lot number not available. Device manufacturing date is dependent on lot number, therefore, unavailable. Return requested for awl/probe/tap driver. No parts have been received by manufacturer for analysis.
 
Event Description
A medtronic representative reported that, while in a spine procedure, the site's the apt driver was coming unscrewed during use. The surgeon switched to a different instrument to continue the procedure. No further details regarding the damage, or how it occurred, were provided. The surgeon completed the procedure with the use of the navigation system. There was no delay of therapy. There was no impact on patient outcome.
 
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Brand NameAWL/PROBE/TAP DRIVER
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
judith ericson
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key5474584
MDR Text Key39526085
Report Number1723170-2016-00275
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 03/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAPT DRIVER
Device Catalogue Number963-799
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 Received02/03/2016
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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