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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 Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. No parts have been received by the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation system during an electrode and probe placement. It was reported that the verification with the imaging system was not successful because merging the scans between the imaging system and the mri failed. All the screws seemed to be misplaced while during navigation. The errors were around. 5mm. The registration of the patient was made by tracer registration. Afterwards, the site noticed that there were bad merges so they continued to trust the previous navigation placement. Once they finished the surgery, the site checked again that the navigation was accurate by touching known anatomical points of the patient's face. The surgery was completed with no delay and with no impact to the patient.
 
Manufacturer Narrative
Analysis on the software resulted in no failure being found. Analysis states that the software was functioning as designed. If information is provided in the future, a supplemental report will be issued.
 
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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
lillian lynn
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7665419
MDR Text Key113283054
Report Number1723170-2018-03153
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 12/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2016
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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