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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 Erratic or Intermittent Display (1182); No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to site to test the equipment. Representative reported that one of the pins on the inner section of the fischer connection were bent. Representative replaced surgeon monitor cable. Issue resolved. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect cable has been received by the manufacturer for evaluation. The cable was missing a pin of the fischer connector. The pin has been broken off and is missing. This is the vsync signal. Cable passed continuity test without any opens.
 
Event Description
A site representative reported that during cranial resection, the monitor of the navigation system unexpectedly displayed "no signal or sync". Reseating the cable did not resolve the issue. The procedure was completed with the use of navigation. There was no delay to procedure. No impact on patient outcome.
 
Manufacturer Narrative
The monitor cable for the navigation system was returned to the manufacturer for evaluation. Testing found that the pin was damaged on the cable and interfered with the vsync signal. 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.
 
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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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7342319
MDR Text Key102518126
Report Number1723170-2018-01146
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
Type of Report Initial,Followup
Report Date 04/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
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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