Safety Alert for Product name: Implantable Neurostimulator for Deep Brain Stimulation (Anvisa registration number: 10339190485), Active Rechargeable Programmable Neurostimulator RC (Anvisa record number: 10339190528), Activa® SC Programmable Neurostimulator (Anvisa registration number: 10339190338), DBS Extension Kit for Deep Brain Stimulation (Anvisa registration number: 10339190463); Neurostimulator Medtronic Spelling Model 7426 (Anvisa registration number: 10339190191), Medtronic Kinetra Neurostimulator Model 7428 (Anvisa registration number: 10339190152) /// Lots: ALL LOTS /// Product risk class: IV - maximum risk.

Safety alert

1904

2016-05-25

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

These are two field actions (fa 711 and fa712). the first is intended to "notify information that will be included in the medtronic deep brain stimulation (dbs) label in connection with the activa® pc, activa® sc and activa® rc devices. this information also applies to patients previously implanted with the kinetra® and soletra® devices. the update concerns an event reported on inability to swim after implantation and the initiation of dbs therapy for parkinson's disease in an experienced swimmer. the patient achieved an excellent result with dbs therapy to control the symptoms of the disease and did not present evidence of the specific motor coordination symptoms identified in the dbs labeling. " the second objective is to "notify information that will be included in medtronic's brain deep stimulation (dbs) label in connection with the tunneling procedure related to dbs extensions model 37086. the labeling updates also clarify possible risks that have been reported with the dbs implant procedure. " the company's goal in sharing this information is to assist the user in the dbs procedure, patient selection, informed consent, and post-implant follow-up of patients treated with dbs therapy. " the conclusion of the company's risk assessment for tunneling is as follows: "post-marketing surveillance of medtronic for dbs therapy has identified the following events or serious injuries associated with tunneling not present in the current dbs labeling. the following events are associated with the dbs implant and the tunneling of the extension of the electrode to the ni (implantable neurostimulator): cases of accessory nerve injury of the spine; severe bleeding or vascular injury; an extension implanted incorrectly through the ribs and that is next observed near the heart that requires an evaluation; very superficial tunneling resulting in an extension that came out and entered again in the neck and that had not been discovered until the removal of the surgical dressing. these events occurred in approximately 0.008% of the tunneling procedures. note: the specific model of the tunneling tool associated with patient injuries has not been reported in many of these events. thus, medtronic is intended to notify you of information that will later be included in the brain deep stimulation (dbs) labeling in connection with the tunneling procedure related to dbs extensions model 37086. ".

Action code: FA 711 and FA712 /// Classification of field action: Update, correction or supplementation of instructions for use /// Loss of coordination may be a side effect of DBS therapy and may result, for example, in inability to swim. Patients should be aware that participation in any activities that require coordination that they were previously able to perform may put them in an undue situation; therefore, these activities should be performed under supervision after DBS therapy is initiated for the first time and after scheduling changes until the effects of DBS therapy on coordination are understood. During the implantation of DBS, the healthcare professional should be cautious during the tunneling of the extension of the electrode to the SNI to prevent the tunneling from becoming too deep or too superficial, as this could lead to serious injury. Complications or effects related to the tunneling procedure may include injury to nerve tissue (such as the accessory nerve of the spine), vascular injury that can result in prolonged hospitalization and tunneling through an unwanted anatomy (such as between the ribs and into the thoracic cavity). / / LETTER TO THE CUSTOMER IN ANNEX.