The oticon medical representative reported the inability to communicate with the cochlear implant.Despite the antennas, magnets, cables and processors changes, the problem persists.At this stage the explantation of the device has been planned, the date of the explantation has not been communicated.
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While this device has gained initial pma approval, it has not been commercialized, imported or sold in the us and no implantations have been performed as of the date of this report.The implant neuro zti cla was not explanted as of the date of this report.Currently, this event is not a serious injury.Follow-up report will be submitted once the device explanted.The subject device is part of the voluntary field corrective action initiated for neuro zti on (b)(6) 2021 (international recall #211014).
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