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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2016
Event Type  malfunction  
Manufacturer Narrative
On 11/07/2016 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. - return requested. Replacement mobile field generator shipped to site 11/04/2016. Medtronic investigation of returned suspect emitter and axiem box finds a communication error when the field generator was connected to the axiem box. Emitter would report unable to read port off and on but mostly shows a communication error. Electrical failure - red status / no tracking. On 11/10/2016 in trouble-shooting, the medtronic representative plugged in the emitter noted being unable to click the mouse. Another axiem box and emitter were plugged into original axiem box was able to click the mouse. When plugged the original emitter into the second axiem box, was unable to use the mouse. - no parts have been received by manufacturer for analysis.
 
Event Description
A medtronic representative received a report that, while in a cranial procedure, the site's navigation system mouse was unable to "click" after scan load. Noted was that after loading the scan into the navigation system, the mouse pointer was still able to be moved, however, clicking the mouse no longer worked. The site brought in their second navigation system and the issue repeated once the scan was loaded. Other scans did not cause this issue. The surgeon opted to continue and completed the procedure without the use of the navigation system. There was no delay of therapy reported. There was no impact on patient outcome.
 
Manufacturer Narrative
Engineering analysis of returned suspect field generator finds that the coil continuity test passed. 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
kristianna bilan
826 coal creek circle
louisville, CO 80027-9710
7208902338
MDR Report Key6137124
MDR Text Key61207524
Report Number1723170-2016-05611
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
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 12/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2016
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 Manufacturer11/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2013
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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