It was reported that the patient had a globus pallidus lead hooked up the right clavicular rechargeable device and a subthalamic nucleus lead hooked up to the left clavicular primary cell device.The patient was seen due to routine programming.There was poor globus pallidus outcome.The globus pallidus therapy was turned off due to side effects.It was noted that the patient still needed to recharge if the device was off.It was noted that the subthalamic nucleus was fine with no issues.(b)(6) 2014 lfc (hcp): additional information received reported the cause of the event was a misplaced globus pallidus lead or right brain.The lead was not in target, the right globus pallidus was planned.Patient had a brain mri in (b)(6) 2013 that showed the lead on the right was misplaced.The subthalamic nucleus was reprogrammed to optimize therapy and globus pallidus was turned off, (b)(6) 2013.Signs and symptoms associated with the event were slurred speech, severe muscle spasms, imbalance, and swallowing problems.The patient had not required hospitalization.Patient outcome was serious injury/ illness, recovered without sequelae.The patient had bilateral subthalamic nucleus that were effective stimulation.Side effects resolved when turned off the right lead and reprogramming the subthalamic to optimize therapy results.
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Concomitant medical products: product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v297034, implanted: (b)(6) 2009, product type: lead; product id 37601, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v222841, implanted: (b)(6) 2009, product type: lead; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37651, serial# (b)(4), product type: recharger; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead.(b)(4).
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