It was reported that the physician¿s assistant (pa) called the reporter stating therapy impedance was high.The reporter did not have the settings or all of the impedance readings.The reporter stated that this may have been the first follow-up since implant and the patient was in for a suture check.The patient also complained of shocking down her jaw and leg that occurred every four to five minutes.The shocking would go away when the device was turned off.Palpation did not show anything and the ¿left was fine.¿ the following day it was reported that the patient experienced shocking and a feeling of parasthesias in the left face, neck, tongue, cheek, and even in her leg that occurred every four to five minutes.It was also noted that during a clinician programmer programming session when the programmer head was pressed up against the implantable neurostimulator (ins) pocket she ¿felt a little something at the pocket.¿ the patient was seen by the pa the day prior to the report and her impedances were checked.They looked to be within normal range, but it was noted that the clinician programmer indicated the therapy impedance was high.The reporter stopped by the clinic during the session and also got a high therapy impedance.They decreased the patient¿s voltage from 3 volts to 2.8 volts and all of her shocking and parasthesias went away.The sensation that occurred when the programmer head touched the pocket site also went away.The patient had had good therapy since the most recent ins replacement and continued to get therapy after voltage was changed.They planned to keep an eye on the patient going forward for any changes.The patient was scheduled to be seen in (b)(6) 2014.Three days later it was reported that the patient still felt the shocking sensation, so the doctor was making arrangements to see her again the week of the report.Nine days later it was reported that the patient was to be seen again on (b)(6) 2014 for further investigation.The patient was tentatively scheduled for an extension revision.Additional information was requested, but was not available as of the date of this report.
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Concomitant medical products: product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(4) 2008, product type: lead.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2008, product type: lead.(b)(4).
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