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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735665
Device Problem Imprecision (1307)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information: device manufacture date provided. Correction: unique device identification (udi) updated to proper value. There was no reported delay to the procedure due to this issue. There was no impact on patient outcome. The surgeon opted to complete the procedure without the use of the navigation system.
 
Manufacturer Narrative
The archive from the procedure was sent to medtronic for evaluation. It was reported that the exam was not to protocol as the spacing and slice thickness varied.
 
Manufacturer Narrative
A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined.
 
Manufacturer Narrative
Device manufacturing date is unavailable. No parts have been received by the manufacturer for evaluation. Part not returned for analysis.
 
Event Description
A site representative reported that, while in a cranial resection, a 3 centimeter imprecision was observed. At the beginning of the procedure, accuracy on known anatomical landmarks was sufficient. The representative reported that there was no brain shift. The representative reported that the had difficulties verifying a probe between the initial accuracy check and when the imprecision was noted.
 
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Brand NameSTEALTHSTATION S8 PREMIUM 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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7120980
MDR Text Key103038928
Report Number1723170-2017-05120
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2017
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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