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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 Unstable (1667)
Patient Problem No Patient Involvement (2645)
Event Date 06/28/2016
Event Type  malfunction  
Manufacturer Narrative
No patient involvement. The device lot number was not reported by the site and the device was not returned, therefore the lot number and mfg date cannot be determined. The suspect device was not returned. A hospital representative reported that central processing had cleaned and lubricated the pad (precision aiming device), allowing it to clamp down. There was apparently something in the screw. Not returned by customer.
 
Event Description
A medtronic representative reported the site needed a new precision aiming device for the vertek biopsy probe as it is no longer tightening properly at the junction closest to where it connects to the vertek arm. No patient involvement.
 
Manufacturer Narrative
Device manufacture date was unavailable as a valid lot number was not provided.
 
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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
kristianna bilan
826 coal creek circle
louisville, CO 80027
7208902338
MDR Report Key5830133
MDR Text Key50730129
Report Number1723170-2016-01969
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954276
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 08/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number960-539
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 Received07/28/2016
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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