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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 Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: product, unique device identification (udi) and associated fields updated to proper value.
 
Manufacturer Narrative
Correction: product, unique device identification (udi) and associated fields updated to proper value.
 
Manufacturer Narrative
Patient information was unavailable from the site. A medtronic representative went to site to test the equipment. Representative was unable to the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. No parts were replaced. No parts have been received by manufacturer for evaluation. The logs for the navigation system were reviewed by medtronic personnel. However, the logs provided no additional insight into the probable cause of the anomaly.
 
Event Description
A site representative reported that during a procedure the display of the navigation system was flickering and then froze. Site verified all connections. During troubleshooting, site reseat power to video splitter and verified all video cables on system but could not resolve the issue. Rebooting the system resolved the issue and video was restored. Site proceeded with procedure. The procedure was completed with the use of navigation. No information was provided on delay to procedure and patient impact.
 
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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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key6880251
MDR Text Key102997609
Report Number1723170-2017-03851
Device Sequence Number1
Product Code HAW
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,Followup
Report Date 01/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2017
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2011
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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