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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 PREMIUM SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 9735665
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No parts have been received by the manufacturer for evaluation. Part not returned for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used for a cranial resection. It was reported that the patient scan was tilted back and rotated, resulting in the registration dots not appearing in the correct location. No re-registration was attempted as the surgeon did not need navigation and opted to abort navigation. There was no impact to patient. There was no reported delay to the procedure due to this issue.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that the reported issue could not be replicated. The system then passed the system checkout and was found to be fully functional.
 
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Brand NameSTEALTHSTATION S8 PREMIUM 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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7863868
MDR Text Key119802722
Report Number1723170-2018-04520
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9735665
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
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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