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 october 14th, 2021 (international recall #211014).
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The patient reported that the implant had suddenly stopped working.An in vivo analysis was performed by the oticon medical representative on (b)(6) 2022.Oticon medical representative did not perform the impedance measurement and electrical artefacts analysis due to the impossibility to connect with the implant.Despite changes in magnets, antennas and sound processor, the results remained similar.The decision to explant the patient was made by the medical team.The expected explant date is not known at this stage.
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