It was reported that stimulation was turning off on its own and the patient did not know what was causing it.The patient was not feeling confident with the patient programmer and inquired if he was reading the programmer right.The patient had had programming done in (b)(6) 2015 and programming was not helping with symptoms.The patient had called their healthcare professional about this.On (b)(6) 2015, the implantable neurostimulator (ins) was turned off and he was seeing stimulation at 2.5v on one side and 3.5v on the other side and it said off on the top.The ins was turned back on.The ins had turned off on saturday prior to the date of this report and it was a normal day.It was off on monday and the left arm was paralyzed, he could not lift his arm or move his elbow over his shoulder.The patient takes 9 doses of sinemet and had stated he had ¿worst days and bad days and the bad days are not good.¿ the patient was in a wheel chair.Further follow-up is being conducted.If additional information is received a supplemental report will be submitted.
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Concomitant products: product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 3389s-40, lot # v939343, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, product type extension.(b)(4).
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