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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 No Display/Image (1183); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site.A medtronic representative went to the site to test the equipment.Troubleshooting found that the power supply for the navigation system required replacement.The representative then returned to the site and replaced the power supply to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts have been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that, while in a procedure, the surgeon monitor lost display functionality.There was no known impact on patient outcome.No additional information was provided.
 
Manufacturer Narrative
The power supply for the navigation system was returned to the manufacturer for evaluation.Testing found that the chassis had an open fuse on the board.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.
 
Manufacturer Narrative
Additional information: additional information was received from a manufacturer representative.It was reported the procedure proceeded with the staff cart monitor.There was no negative impact on the patient.
 
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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
pa chia vue
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7248155
MDR Text Key99235576
Report Number1723170-2018-00430
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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,health
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 04/12/2018
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 Number9733856
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/16/2018
Initial Date FDA Received02/07/2018
Supplement Dates Manufacturer Received02/15/2018
03/28/2018
Supplement Dates FDA Received03/05/2018
04/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2013
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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