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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 Problems Imprecision (1307); Difficult to Open or Close (2921)
Patient Problem Injury (2348)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device serial number, unavailable at the time of filing. Udi not available for this system at time of filing. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable at this time. No parts have been received by the manufacturer for evaluation. No parts returned for analysis.
 
Event Description
A manufacturer representative reported an issue with the navigation system. During an electrode and probe placement procedure the leads needed to be revised. The patient was affected. No additional information was available.
 
Manufacturer Narrative
A manufacturer representative went to the site to test the equipment. It was identified the gantry door was not closing due to misaligned gantry door covers. The gantry doors were realigned and the switches were adjusted. The imaging system then passed the system checkout and was found to be fully functional. No parts were replaced or returned to the manufacturer.
 
Event Description
A site representative reported that, while outside of a procedure, the imaging system was unable to detect the door was closed intermittently. The button could be held down and the gantry leds would appear and move to their position, but the pendant continued to show door open no matter how long the button was held. Restarting the system allowed the imaging system to register the gantry door as closed. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Additional information: patient information received. Additional case information received, serial number. Correction: supplemental sequence number one inadvertently filed. Should be under 1723170-2018-00838.
 
Event Description
Additional information was received from the site. It was reported that the surgeon accepted the placement during the case. The healthcare provider (hcp) could not find an optimum setting due to the side effects at low voltages. At the time of the initial report, the mri follow up was pending to potentially re-do the case. There was a reported delay to the procedure of less than 1 hour due to this issue. No further information was provided.
 
Manufacturer Narrative
Additional information: device manufacture date provided. Correction: unique device identification (udi) updated to proper value.
 
Manufacturer Narrative
A software analysis was initiated. However, the software evaluation found that a probable cause was unable to be determined.
 
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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
7635267745
MDR Report Key7352007
MDR Text Key102839713
Report Number1723170-2018-01181
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/20/2018 Patient Sequence Number: 1
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