• 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); Unspecified Infection (1930); Iatrogenic Source (2498); Blood Loss (2597)
Event Date 05/20/2015
Event Type  Injury  
Manufacturer Narrative
Patient identifier was not provided by the journal article author. Patient specific ages were not provided; age range 50-75, therefore 63 years was used. Patient sex was not made available. There were 19 male and 11 female; therefore male was used. Patient weight was not provided by the journal article author. Death date is approximated as the exact dates were not made available. The article was received for publishing on (b)(6) 2015 and used as the date. Event date is approximated as the exact dates were not made available. The article was received for publishing on (b)(6) 2015 and used as the event date. Citation: jidong, l. , & l, song. (2015). Analysis of clinical effectiveness of neuronavigation-assisted burr hole external drainage in treatment of thalamic hemorrhage, 23(8), 54-55. Doi:10. 3969/j. Issn. 1006-9852. 2016. 11. 006. Multiple attempts have been made to obtain additional information. No additional information has been provided except that there were no specific relationships between the navigation system and reported complications in the journal article. Per the author and surgeon, those complications usually result in disease state. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer. Journal article; not returned by customer.
 
Event Description
Per article, the authors reported use of the navigation system and there were patient events reported. The article is in (b)(4) and was summarized by medtronic representatives. The study included 60 patients, 30 of which had navigated procedure. Of this group, 19 male and 11 female, age range 50-75. The indication was for burr hole drilling and external drainage for treatment of thalamic hemorrhage. Adverse events summarized for the navigated group: rebleeding ¿ 3 patients. Intracranial infection ¿ 1 patient. Upper gi tract bleeding ¿ 1 patient. Central fever ¿ 6 patients. Lung infection ¿ 4 patients. The death rate (due to disease state, no connection with navigation alleged) was 3. 3%. No further details were provided or additional information on adverse events. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
 
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
oksana ditolla
826 coal creek circle
louisville, CO 80027
MDR Report Key6309241
MDR Text Key66762591
Report Number1723170-2017-00376
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,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
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 Received01/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2014
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: 02/07/2017 Patient Sequence Number: 1
-
-