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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 Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
Event Type  malfunction  
Manufacturer Narrative
Patient ethnicity and race not available from the site. A medtronic representative went to the site to test the equipment. The navigation system then passed the system checkout and was found to be fully functional. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used for a catheter placement procedure. The issue occurred intraoperatively during the navigate task and delayed surgery by less than one hour. It was reported that there was intermittent tracking during a cranial em case. The surgery was completed with navigation and the surgeon felt accurate through out the case. There was no impact on patient outcome.
 
Manufacturer Narrative
Additional information: manufacturing date updated.
 
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 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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7635156
MDR Text Key112227175
Report Number1723170-2018-02982
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2009
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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