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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 Imprecision (1307)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
A medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. Software investigation completed. Findings are that symptom was caused by frame movement. Software is functioning as designed.
 
Event Description
A medtronic representative reported that, while in a tumor resection procedure, the surgeon alleged an inaccuracy of approximately 2 centimeters occurred. It was reported that the frame moved, and the surgeon was unable to re-register as the patient was already draped. Issue occurred after registration, site broke the drape with the patient reference frame. In trouble-shooting, they re-positioned the patient reference frame and articulating arm, replaced spheres on all instruments, re-positioned the camera and performed touch-n-go registration. A 1. 7 millimeter registration error metric was received. Surgeon tested accuracy and deemed being approximately 3-6 millimeters inaccurate. The surgeon opted to discontinue the use of their navigation system and continued the procedure to completion without the use of the navigation system. There was no delay of therapy reported. There was no impact on patient outcome reported.
 
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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
judith ericson
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6142564
MDR Text Key61405288
Report Number1723170-2016-05628
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 Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
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 Received11/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2016
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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