It was reported to aesculap inc., via the annual activl enhanced safety surveillance study (ess) covering a reporting period from (b)(6) 2023 to (b)(6) 2023, that an unknown activ l device was implanted on an unspecified date at the l5-s1 level.According to the complainant the patient experienced a sensory neurological event at the l5-s1 level on an unspecified date.Reportedly there was minor numbness in a radicular distribution that resolved spontaneously in a few weeks with time, gabapentin and a medrol dose pack the adverse event is filed under aic reference (b)(4), (b)(4).2916714-2024-00061, 2916714-2024-00062.
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