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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC S7 INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Data Problem (3196); Intermittent Communication Failure (4038)
Patient Problem No Patient Involvement (2645)
Event Date 12/08/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as there was no patient involved in this event. A medtronic representative tested the data set over the phone. Testing revealed that the system was working as intended. The ct was used as the reference and was merged with the other data sets. On the registration screen the ct was still the registration exam. The system passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from the manufacturer representative regarding a navigation device being used outside of procedure. It was reported that the patient was not yet present in the room. Site merged ct with 4 mri's. The correct model appeared in planning. However, when they changed to registration, the incorrect model (mri) appeared selected on the screen and the exam selected as the "select exam" value was set to the mri. The manufacturer representative was able to change it to the ct but was not sure why the incorrect exam was selected as reference. There was no patient involved in the event.
 
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Brand NameS7
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 Key8566646
MDR Text Key143697021
Report Number1723170-2019-02064
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/24/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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