Related manufacturer reference number 1627487-2020-00715.It was reported that during the patient¿s scs trial they were experiencing neurological side effects which included cramping in the patient¿s left arm and fingers, as well as what the patient described as a rubber band around their fingers.When stimulation was turned on, the patient would get a shocking sensation.Diagnostics revealed low impedance.A cat scan determined the lead was touching the spinal cord.The patient was transferred to a hospital to undergo an mri and further evaluations.
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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