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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 Unstable (1667)
Patient Problem No Patient Involvement (2645)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Onsite investigation was preformed and it was discovered that a loose cable connection caused the reported event. Issue was resolved when the cable connection was re-seated properly. No further issues were reported. No parts were replaced or returned. A full system check-out was completed and all tests passed. Full system functionality was confirmed and the system was returned to service.
 
Event Description
A medtronic representative reported that the navigation system became unstable during the use of dicom q/r application. There was no patient present when this issue was identified.
 
Manufacturer Narrative
 
Manufacturer Narrative
Device manufacture date inadvertently left off of follow up number 1.
 
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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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key6373540
MDR Text Key68981796
Report Number1723170-2017-00948
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K050438
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
Report Date 06/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
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 Received06/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2012
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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