It was reported there was a shocking or jolting sensation.They had shocking in the pocket and down the arm.It was unknown how long it had occurred and it was unknown if there were any falls or trauma associated with the change.There was high impedance >4,000 ohms on monopolar configuration.Both of the left and right monopolars were out of range but the right was much higher; the range was 16,000-20,000 ohms.The left side ranged from 3,300-5,600 ohms.The patient had already been referred to a neurosurgeon for possible revision.Additional information received reported they were going to do intraoperative troubleshooting because of a suspected issue with the electrodes.They would also check the extensions.The surgical procedure would happen on (b)(6) 2014.No outcome was 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.
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Concomitant medical products: product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead.Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead.(b)(4).
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