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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); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the power box of the navigation system and computer were replaced.The system then passed the system checkout and was found to be fully functional.The computer for the navigation system was returned to the manufacturer for evaluation.Testing found that the computer had a bad sector on the hard drive.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Event Description
Medtronic received information that, while outside of a procedure, the display of the navigation system was intermittently losing functionality.There was no patient present when this issue was identified.No additional information was provided.
 
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Brand Name
STEALTHSTATION S7 SYSTEM
Type of Device
NEUROLOGICAL 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 Key7455388
MDR Text Key106385031
Report Number1723170-2018-01669
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450968
UDI-Public00613994450968
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/23/2018
Initial Date FDA Received04/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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