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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 Device Stops Intermittently (1599); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/10/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacturer date provided. Correction: product and associated fields updated to proper value.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Udi not available for this system at time of filing. Device manufacturing date is unavailable at this time. A medtronic representative inspected the system onsite and confirmed the reported issue. The camera cable was replaced and the issue resolved. A full system check-out was completed following part replacement and all tests passed. Full system functionality was confirmed and the system was returned to service. The suspect part has not returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while outside of a procedure, there was intermittent camera power/communication failure with the navigation system. While using the system for 10 to 20 minutes the camera shuts down completely and a low beeping sound from the staff cart is heard. There was no patient present when this issue was observed.
 
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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
7635267745
MDR Report Key7231519
MDR Text Key103091199
Report Number1723170-2018-00474
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeTK
PMA/PMN Number
K050438
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
Report Date 02/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2015
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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