It was reported that the patient felt a tingling at the implantable neurostimulator (ins) site in their left chest.It was unknown if therapy had been titrated down at implant as suggested due to differences in voltage between legacy and current devices.Threshold testing had not been redone.Imaging had not shown any visible issues with the system.The issue was unresolved at the time of this report and the healthcare professional planned to address the tingling problem surgically, but they had since decided to do no intervention at the time of this report.Impedances of the left globus pallidus (gpi), right abdomen placement and right gpi, left chest subclavicular placement were run at 0.7 and 3.0v.All impedances were within normal limits.Follow up with the patient healthcare professional (hcp) indicated that the cause of the event was not determined and it was unknown if it was device related.X-rays and reprogramming was done.No intervention or outcome was provided regarding the event.Further follow-up is being conducted to obtain this information.Refer to manufacturer report # 3004209178-2014-20781.
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Product id 37602, serial# (b)(4); product type implantable neurostimulator product id 37602, serial# (b)(4); product type implantable neurostimulator product id 3387s-40, lot# v679192, implanted: 2011 (b)(6) product type lead product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387s-40, lot# v679192, implanted: 2011 (b)(6); product type lead product id 7482a95, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7438, serial# (b)(4); product type programmer, patient.(b)(4).
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