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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 Problems Unstable (1667); Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information was not made available from the site. Device lot number, or serial number, not available. Mfg date: device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No parts were replaced. No parts have been received by manufacturer for analysis. No further issues have been reported. Part not received by manufacturer.
 
Event Description
A medtronic ent representative received a report from the site that, while in a cranial procedure, their biopsy guide was damaged. The surgeon was using a wench to try and tighten and lock the position, however, it was still too loose. No further details regarding the damage, or how it occurred, were provided. The surgeon opted to continue and completed the procedure with the use of the navigation system. There was no delay of therapy reported. There was no impact on patient outcome.
 
Manufacturer Narrative
Correction: a medtronic representative, following up with the site, reported that the procedure was completed on (b)(6) 2016 and the medtronic representative was not notified of the event until 30-mar-2016. Event date now corrected.
 
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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 80027-9710
7208902338
MDR Report Key5602228
MDR Text Key43481399
Report Number1723170-2016-00619
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 05/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number960-539
Device Lot Number140505
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 Received04/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2014
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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