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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. STEALTHSTATION I7 NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. STEALTHSTATION I7 NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Hemorrhage, Extradural (1890); High Blood Pressure/ Hypertension (1908)
Event Date 07/09/2020
Event Type  Injury  
Event Description
Laser fiber length was incorrect causing fiber to extended beyond the target and into the brainstem. Patient with a history of metastatic adenocarcinoma as well as multiple sclerosis presented to the or for a biopsy and possible laser ablation. Surgery was being performed with the stealth navigation system and there were 3 medtronic reps present for the case. Biopsy portion of the case went as planned and surgeon moved onto the next portion of the case. Measurements for 3 different laser fiber lengths were taken with trajectory confirmation of each. The 3 separate laser fibers were measured to appropriate length and labeled appropriately. Lengths were confirmed and double checked. The 1st fiber was inserted without difficulty. When the 2nd laser fiber was being placed it was discovered that the length generated was too long. This laser fiber was immediately removed. Patient became hypertensive and there was concern for possible brainstem injury. Decision to abort the procedure and not perform the laser ablation was made. Patient was brought to ct and it was identified that there was bleeding around the brainstem.
 
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Brand NameSTEALTHSTATION I7
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC.
826 coal creek cir.
louisville CO 80027
MDR Report Key10372387
MDR Text Key201888733
Report Number10372387
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/04/2020
Event Location Hospital
Date Report to Manufacturer08/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/06/2020 Patient Sequence Number: 1
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