Alerta De Seguridad para Trade name: DBS ELETRODE FOR DEEP BRAIN STIMULATION; DEEP BRAIN STIMULATION ELECTRODE; KIT CATETER DBS ELECTRODE FOR DEEP BRAIN STIMULATION Technical name: DBS ELETRODE FOR DEEP BRAIN STIMULATION; DEEP BRAIN STIMULATION ELECTRODE; KIT CATETER DBS ELECTRODE FOR DEEP BRAIN STIMULATION ANVISA registration number: 10339190484; 10339190549; 10339190339 Hazard Class: IV Affected Model: 3387S-40, 3389S-28, 3389S-40 and 3391S-40

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

If your surgical procedure involves the use of Medtronic's DBS depth limiter, Medtronic recommends the following: • For the implanted product: If the product has already been implanted, no action is necessary once the electrode placement at the target site was confirmed by intraoperative test stimulus, imaging and / or efficacy of the therapy. • For the product to be implanted: If it is suspected that the depth limiter has not been properly attached to the electrode, do not use and complete the procedure using a depth limiter from another Medtronic DBS electrode kit. As stated in the DBS electrode implant manual, Medtronic recommends checking the effect of the stimulus during the implant procedure and using imaging techniques to confirm electrode placement. #### UPDATED ON 7/24/2017, Medtronic Company submitted the field action completion report verifying the submission of the safety notice.