Continuation of concomitant products: product id 97755.Lot# serial# (b)(4).Implanted: explanted: product type recharger.Information references the main component of the system.Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), ubd: , udi#: (b)(4).Date is approximate.
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that they were having issues with consistently communicating with the stimulator when using the recharger.The patient stated they charge once a day or every other day, a few mins "here and there", and the stimulator is currently at 30%.The patient stated they tried moving the paddle of the recharger around and using passive recharge mode but the issue would not resolve.The patient stated the recharger, where the paddle and cord meet and at the relay box, would get "fire hot" and burned the patient's skin.The patient stated they put electrical tape around the cord, but the patient was still having issues with the recharger.An email was sent to the repair department to replace the recharger.
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