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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2016
Event Type  malfunction  
Manufacturer Narrative
No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a transphenoidal procedure, the surgeon alleged an inaccuracy occurred to medial lateral. No specific measurement of the alleged inaccuracy was provided. The patient was re-registered 3 times and the site switched navigation systems. In trouble-shooting, confirmed the exam was to proper protocol and that the articulating arm had not moved. The surgeon opted to discontinue the use of the navigation system to continue the procedure to completion. Delay in therapy was less than one hour. There was no impact on patient outcome.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
 
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Brand NameSTEALTHSTATION S7 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
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6178731
MDR Text Key62533913
Report Number1723170-2016-05770
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,Followup
Report Date 03/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
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 Received11/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2012
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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