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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733858
Device Problems Human-Device Interface Problem (2949); Audible Prompt/Feedback Problem (4020)
Patient Problem No Patient Involvement (2645)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the initial complaint was confirmed and the cable was replaced. The system then passed the system checkout and was found to be fully functional. The surgeon lcd cable was returned to the manufacturer for analysis. Analysis found that there was an open at pin 10 that was found to be the electrical issue. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of procedure. It was reported that there were sizzle noises coming from the surgeon screen speakers. The issue occurs when touching the connector towards the main cart and the sizzle comes and goes. There was no patient present when this issue was identified.
 
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Brand NameSTEALTHSTATION® S7
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8529407
MDR Text Key142492085
Report Number1723170-2019-01844
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733858
Device Catalogue Number9733858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2012
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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