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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 Problem Device Operates Differently Than Expected (2913)
Patient Problems Tissue Damage (2104); Brain Injury (2219); Iatrogenic Source (2498)
Event Date 04/10/2017
Event Type  Injury  
Manufacturer Narrative
In trouble-shooting, the medtronic representative reviewed the exam archive and found that the surgeon was using a cta with a large field of view (fov) that included the sternum. The tracer appeared shifted laterally, since there were no points shown collected on the nose, only points showing next to the nose along the cheek. It is suspected the initial blue dots appeared shifted as well and were not corrected and accuracy was not confirmed following tracer. - return requested. No parts have been received by manufacturer for analysis. - on 04/19/2017 a medtronic representative performed a navigation system check-out. Hardware and instruments testing passed. - on 05/02/2017 software investigation completed. Findings are that analysis of patient logs shows the patient exam was not to protocol and tracer pattern was not adequate. Software is functioning as designed. - medtronic representative reported the site has received additional training in proper protocol for patient exam and tracing patterns.
 
Event Description
The physician in the case reported that while in a cranial biopsy procedure with the navigation system was inaccurate. A sample was taken, and sent for testing. However, when the biopsy was reviewed, it was healthy brain tissue. There was no delay to the case and the patient is scheduled for revision surgery with another navigation system on (b)(6) 2017. A medtronic representative reported that while in a cranial biopsy procedure the surgeon alleged an inaccuracy occurred. No specific measurement, or direction, of the alleged inaccuracy was provided. A sample was taken, and sent for testing, however, when the biopsy was reviewed, it was found to be healthy brain tissue. There was no delay to the case and the patient is scheduled for revision surgery with another navigation system on (b)(6) 2017.
 
Manufacturer Narrative
Correction: to the fda results and conclusion codes. As reported on initial mdr, software was functioning as designed. Patient exam was not to protocol and tracer pattern was not adequate.
 
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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
oksana ditolla
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7633987612
MDR Report Key6567600
MDR Text Key75181142
Report Number1723170-2017-01784
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/15/2017 Patient Sequence Number: 1
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