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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 Problems Unstable (1667); Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 05/25/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device manufacturing date is unavailable. Return requested. Replacement percutaneous pin adapter shipped to site 06/06/2016. Medtronic investigation of returned suspect percutaneous pin adapter finds the device to be in good condition with no apparent physical damage. Known good percutaneous pins inserted easily and were held solid. The starburst adapter attached to frames without issue as well. No problem found. Device found to be fully functional. No further issues have been reported.
 
Event Description
A medtronic representative reported a site's percutaneous pin adapter had a loose j-hook. No further details regarding the damage, or how it occurred, were provided. In trouble-shooting, it was noted that when they attached the percutaneous pin there was more movement. The medtronic representative confirmed the percutaneous pin had the silicone tip. They used another adapter, with the same percutaneous pin, and it fit much more snug. There was no patient present when this issue was identified.
 
Manufacturer Narrative
Device manufacture date 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
amos jarrette
826 coal creek circle
louisville, CO 80027-9710
7208902082
MDR Report Key5745487
MDR Text Key48052005
Report Number1723170-2016-01162
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 07/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2015
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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