Concomitant: product id 7426, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2013-(b)(6), product type implantable neurostimulator.Product id 7482a51, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2014-(b)(6), product type extension.Product id 3389s-40, lot# v210850, implanted: 2010-(b)(6), explanted: 2014-(b)(6), product type lead.Product id 7482a51, serial# (b)(4), implanted: 2010-(b)(6), product type extension, product id 7438, serial# (b)(4), product type programmer, patient.Product id 3389s-40, lot# v561214, implanted: 2011-(b)(6), product type lead.(b)(4).
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(b)(4): the consumer reported that they've had three deep brain stimulator (dbs) devices and they "are not working." no interventions, troubleshooting, potential causes or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.Indications for use: essential tremor movement disorders.
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