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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 Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. External main to camera, internal to main cart cable and internal to camera cart cable have been shipped however resolution has not been confirmed yet. The parts have been received by the manufacturer for evaluation. The returned external main to camera, internal to main cart cable and internal to camera cart cable were found to be in good condition and passed continuity test with no opens or shorts detected. No fault found.
 
Event Description
Medtronic received information regarding a navigation system. It was reported that the main cart and camera cart were not communicating, but the interconnected cable was providing power to the camera cart. A manufacturer representative connected an ethernet cable internally between the two carts and was able to establish connection. The representative reported that when they plugged in the camera cart to cart cable another time, the connection was established briefly, but then did not communicate. There was no patient present when this issue was identified.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the external, internal and camera communication cables were replaced to restore functionality. The system then passed the system checkout and was found to be fully functional.
 
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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
7208902515
MDR Report Key7614444
MDR Text Key111681362
Report Number1723170-2018-02860
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2017
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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