Product id: 7438, serial# (b)(4), product type: programmer, other applicable components are: product id: 7426, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.
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The patient reported that one of the two implantable neurostimulators (ins) stopped working on the morning of two days prior to the report.The patient successfully turned the ins back on (it was the ins implanted under the right collar bone).In the afternoon the same ins turned off again, and despite the patient was checking the battery status regularly, it was shown okay.The patient tried to switch it on a few times, but it was not possible to turn on the ins again.There was no emi disturbances.The patient was implanted all together for 10 years (including previous devices), very experienced and satisfied with deep brain stimulation (dbs).Because it was not possible to switch the ins back on, his doctor was notified immediately since his clinical picture became worsen.A re-implantation of both inss were already scheduled.The inss will be replaced.It was noted the ins implanted under the left collar bone was still working normally and showing okay, 3.61v.There was no patient harm, injury or death.The company representative (rep) additionally reported that they would like to send the patient programmer (pp) for analysis.When communicating with the clinician programmer on "(b)(6) 2016," the left ins showed a status of ¿battery ??? still working.¿ the last time the patient was examined with the clinician programmer was in (b)(6) 2014, the battery¿s status at that time were: left chest battery 3.71v and right chest battery 3.72v, both hemispheres bipolar settings.Left hemisphere: 0-, 1+, 3.5v, pw 150micros, rate 130hz.Right hemisphere: 1-, 2+, 3.5v, pw 150micros, rate 130hz.Clinical picture worsened was further clarified as dystonia of the left side of the body (contralateral to the impaired ins); torticollis, trunk, leg and art dystonia that was painful too.Troubleshooting was performed, the patient was clinically examined by a movement disorders specialist on (b)(6), one day after the deterioration started.The status of inss were checked too and the right one was non responsive.The patient did not report any falls or trauma.Both inss were replaced on (b)(6) 2016.The indication for use included generalized dystonia.
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