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

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.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL 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 Key: 6309241
• MDR Text Key: 66762591
• Report Number: 1723170-2017-00376
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening