It was reported the patient had an altered mental status, specifically a manic episode.It was reported that there were no alleged product issues, no troubleshooting was performed, and no action was required as a result of the event.It was reported the patient¿s status was unable to be obtained at time of this report.Additional information received reported that hospitalization was required as a result of the event.The patient outcome was serious life-threatening illness/injury recovered without sequelae.The symptoms associated with the reported event included mania.The cause of the event was unknown.It was unknown if the event was due to the implantable neurostimulator (ins) or the lead/extension.It was noted that next to reprogramming ¿device turned off¿ was written.
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Product id: 3387s-40, lot# va05qgb, implanted: (b)(6) 2013, product type: lead.Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer.Patient product id: 3387s-40, lot# va074jr, implanted: (b)(6) 2013, product type: lead.(b)(4).
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