Other applicable components are : product id: 977a290, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Product id: 37081-40, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: extension.Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 18-oct-2020, udi#: (b)(4); product id: 37081-40, serial/lot #: (b)(4), ubd: 19-sep-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was trialing a neurostimulator.It was reported that after spinal cord stimulation testing and post-operative, the patient suddenly described that he was not able to move his left leg anymore.The hcp was informed and tested that with the patient.Approximately one hour later, the hcp called the rep again and informed them that now the patient wasn't able to move both legs.They assumed some kind of epidural bleeding and stopped the testing explanting the electrode and extension.The testing and steering of the electrode was quite challenging before and at the end they found a position approximately at the eleventh thoracic vertebrae (t11) with paresthesia in the left leg of the patient which was the pain area.Impedance was checked and was ok.Power in the operating room was approximately 2 volts.It was unknown if the issue was resolved as of (b)(6) 2018.The patient was alive with injury.The patient had the pre operation status and the patient¿s inability to move their legs was resolved.The healthcare professional (hcp) stated the patient¿s inability to move their legs was due to epidural bleeding.
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