A deep brain stimulation therapy of MEDTRONIC is indicated for the unilateral or bilateral stimulation of the internal pallid balloon (IPG) or the sub-thalamic nucleus (STN) in the following cases: Parkinson's disease: indicated for adjuvant therapy in the reduction of some of the symptoms of Parkinson's disease advanced in patients with a response to levodopa and that is not adequately controlled with medication. Essential tremor and dikinesias: indicated for the suppression of tremor in the upper extremities. Designed for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where tremor constitutes a significant loss of functionality. Dystonia: indicated as an aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia, and cervical ladisthonia (torticollis), for persons 7 years of age or older. Epilepsy: indicated as adjuvant therapy to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or secondary syngeneization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for bilateral stimulation of the internal capsule of the anterior limbus (AIC) as an adjunct to medication and as an alternative for the treatment of chronic compulsive obsessive-compulsive disorder resistant to treatment with deserotonin inhibitors.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: Parkinson's disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: depharkinson disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
extensions for deep brain stimulation, model 7483 and 37086, all series.
Product Description
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: depharkinson disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral or bilateral stimulation of the internal pale balloon (IPG) or the sub-thalamic nucleus (STN) in the following cases: Parkinson's disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Essential tremor and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential contamblor or tremor associated with Parkinson's disease not adequately controlled by medication and where tremor is a significant loss of functionality. Dystonia: indicated as an aid for the treatment of intractable primary chromosome (resistant to medication) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for persons 7 years of age or older. Epilepsy: indicated as adjuvant therapy to reduce the frequency of convulsions in adult patients diagnosed with epilepsy characterized by initial partial seizures with or secondary syngeneization resistant to anti-epileptic drugs. Obsessive-compulsive disorder: indicated for bilateral stimulation of the internal capsule of the anterior limbus (AIC) as complement to medication and as an alternative for the treatment of chronic compulsive obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.