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

Model Number TRIA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Discomfort (2330); Iatrogenic Source (2498)

Event Date 12/29/2014

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided by the journal article author. Patient specific ages were not provided; age range 20-83 years, average 52. 9+/11. 3 year, therefore 53 years was used. Patient sex was not provided. There were 352 male, 263 female; therefore male was used. Patient weight was not provided by the journal article author. Event date is approximated as the exact dates were not made available. Study time frame was january 5, 2012 to december 29, 2014, therefore 12/29/2014 was used. Citation: zhang y. , li j. Y. , li j. P. , wang y. , liu c. , & li y. (2016). Analysis of surgical complications of deep brain stimulation for movement disorders. J clin neurosurg (china), 13(1), 31-34. Doi:10. 3969 /j. Issn. 1672-7770. 2016. 01. 009. Device udi not provided as this product is no longer manufactured. Multiple attempts have been made to obtain additional information. No additional information has been provided. 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 attached article, the authors reported use of a navigation system and there were patient events reported. The article is in (b)(6) and was summarized by medtronic representatives. The study included 615 patients during january 5, 2012 to december 29, 2014. The study included 352 male, 263 female. Age range 20-83 years, average 52. 9+/11. 3 years. Duration of illness 2-20 years. Devices used were the navigation system and dbs electrodes during deep brain stimulation for treatment of movement disorders. Adverse events summarized: hemorrhage ¿ 4 patients, 2 of which had bleeding in the puncture tract. In all 4 patients, revision surgery was not needed. Infection leading to removal of all or part of the implant in 10 patients. Subcutaneous effusion around the implant site (no infection) in 10 patients. Component fracture in 10 patients. Lead malposition or migration in 9 patients. Acute edema in 1 patient. Hardware discomfort, alleviated after re-implant at adjusted position in 1 patient. The interventions for adverse events reported in the article were: for 4 patients with bleeding, the bleeding was reabsorbed and there was no neurological damage. Infection: in 9 patients, the electrode was removed, and re-implanted after 3 months. No details on how the infection was treated. Subcutaneous effusion: treated with incision and external drainage in 2 patients, puncture and external drainage in 8 patients. Resolved in all patients. Hardware discomfort: resolved after reimplantation with adjusted position. Acute edema: resolved after treatment with glucocorticoids. No information on other interventions no further details were provided or additional information on adverse events, interventions and outcome.

• Brand Name: STEALTHSTATION TRIA NAVIGATION 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: 6311670
• MDR Text Key: 66807679
• Report Number: 1723170-2017-00701
• Device Sequence Number: 1
• Product Code: HAW
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TRIA
• Device Catalogue Number: 9730759
• 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 Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2010
• 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: 02/08/2017 Patient Sequence Number: 1