• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Brain Injury (2219); Blood Loss (2597)
Event Date 08/23/2017
Event Type  Death  
Manufacturer Narrative
A medical safety assessment was completed for the reported event, that used the navigation system and navigation instruments (including a non-invasive patient tracker, disposable tracker, and a malleable suction). Per the instructions for use for the non-invasive patient tracker, ¿potential adverse events associated with neurological procedures, though not necessarily associated with use of this device, include but are not limited to: device malfunction, subdural fluid collection, hemorrhage, hematoma with neurological compromise, development of abdominal pseudocyst, seizure, brain swelling, infarction, disturbance of consciousness, motor deterioration, hemiparesis, aphasia, or other neurologic deficit. ¿ operating room records were reviewed but provided no additional information. It is stated that during an additional surgery, no navigation was used, they found the vessel had detached. The patient was put on life support and died a few days after. It was also noted that the surgeon stated the adverse event ¿was not related to navigation, as the tumor was surrounding the artery. ¿.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Event Description
A medtronic representative reported that, while in a transsphenoidal tumor resection, the surgeon made contact with the interior carotid artery which led to a bleed. A non-navigated ring curette was in use when attempting to extract tissue from the patient. Following the bleed, the representative reported that the patient was stabilized and transferred to an endo surgery. During the endo procedure, it was found that the vessel had detached and was sacrificed. The site then placed the patient on life support and expired at a later date. No allegation of deficiency was made against a medtronic product as a non-navigated instrument was in use. The surgeon reported that the tumor was surrounding the artery which led to a known risk of the procedure. There was no reported delay to the procedure due to this issue. No additional information was provided.
 
Manufacturer Narrative
The logs for the navigation system were reviewed by medtronic personnel. However, the logs provided no additional insight into the probable cause of the anomaly. The archive used in the procedure was evaluated by medtronic personnel. The evaluation found that one computed tomography (ct) had been imported and contained 1mm contiguous slices, though the registration performed was not saved to the archive.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
stephanie riley
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key6884504
MDR Text Key102356420
Report Number1723170-2017-03836
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received02/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2013
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: 09/21/2017 Patient Sequence Number: 1
-
-