Concomitant medical products: product id: 977c290, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: lead.Product id: 977c290, serial/lot #: (b)(4), ubd: 31-mar-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information received from the healthcare professional (hcp) via manufacturer representative (rep) reported that the lead was implanted due to indication of pain on level t9/t10.The patient was implanted in the past with several orthopedic spine screw systems.Due to the systems, there was not enough spinal space and it was difficult to implant the lead.After the implant, the patient complained of a lot of pain at the implant site of the lead.Where they got medication for their pain.Yesterday, the patient complained of paraplegic syndrome in the legs.Factors that may have led or contributed to the issue were not applicable.A ct scan was done where there was no epidural injury or bleeding visible.From the anatomical point of view, no abnormalities were existing.It was reported that the physician decided to explant the lead.The patient still complains of paraplegic syndromes but it seems that the symptoms decreased.The issue did not resolve.Additional information received that there was no implantable neurostimulator (ins) implanted.It was a trial with a lead.The patient was getting more and more well after explantation of the lead.
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