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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY GUIDE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 960-539
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
Replacement device shipped to site for issue resolution. No parts have been received by manufacturer for analysis. Site declined to return suspect device.
 
Event Description
A site representative reported that the biopsy guide instrument was damaged. No further details regarding the damage, or how it occurred, were provided. There was no patient present when this issue was identified.
 
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Brand NameBIOPSY GUIDE
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
jasmine birlew
826 coal creek circle
louisville, CO 80027
MDR Report Key6210939
MDR Text Key63475196
Report Number1723170-2016-05953
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K954276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number960-539
Device Lot Number160706
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 Received12/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2016
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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