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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735665
Device Problem Imprecision (1307)
Patient Problem Brain Injury (2219)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: sw kit 9735737 stealth s8 cranial: version: 1. 2. 0. Initial archives showed good 3d model from a ct scan and had a good trace pattern giving an accuracy metric of 1. 1mm. Registration verification showed plan was in the green zone of accuracy. Nothing in the registration that would point to placing the catheter on the wrong side. Patient orientation was correct. A medtronic representative went to the site to test the equipment. Testing revealed that the navigation system functioned as designed. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a catheter placement. It was reported that the doctor had an inaccuracy when placing a catheter, a week prior (using em). The doctor reported that the catheter was placed on the whole side of the head. Surgeon claimed the registration was good and had an accuracy of 1 mm at the target when verifying registration. The site was able to place the catheter correctly without fully removing it. After following up with the doctor regarding the patient, the doctor confirmed no further surgeries were performed for catheter placement. The final placement was established during the initial surgery. The evening after surgery while on the floor, the patient experienced a brain herniation and was currently brain dead. The doctor did not believe this was the result of navigation. Additional information was received from the rep and it was stated that the doctor reported to them that after the vp shunt placement, placement of the catheter was confirmed and it was determined that it was placed on the opposite side of the head. The doctor targeted the right ventricle and it was determined that the catheter ended up in the left ventricle. The doctor felt that this was a result of inaccurate navigation. The rep asked the doctor if there was any injury to the patient and/or if he had to bring them back to surgery to correct the catheter. That was when he stated that the ¿patient was not doing well but that it wasn't because of navigation. ¿ he reported that the night of the surgery the patient experienced an incident on the floor and was now ¿essentially brain dead. ¿ resultingly they will not be coming back to surgery to correct. Follow up information received from the rep reported that the doctor however reiterated that he felt the patient¿s injury and subsequent demise was not a result of the navigation error. He stated that the patient developed a blood clot that was missed and not treated and the eventual herniation was the consequence. The doctor stated the catheter was placed on the right side of the head with the target being in the right ventricle. However, after surgery a ct showed that the end of the ventricular catheter was in the left ventricle. The doctor stated that they did not bring the patient back to surgery. There was no reported delay to the procedure.
 
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Brand NameSTEALTHSTATION S8 SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10431505
MDR Text Key205316587
Report Number1723170-2020-02225
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00643169722187
UDI-Public00643169722187
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 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735665
Device Catalogue Number9735665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2019
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: 08/20/2020 Patient Sequence Number: 1
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