Model Number NEURO ZTI CLA |
Device Problems
Failure to Read Input Signal (1581); Communication or Transmission Problem (2896)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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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 october 14th, 2021 (international recall #211014).
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Event Description
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The oticon medical representative reported the inability to communicate with the cochlear implant.Despite the antennas, magnets, cables and processors changes, the problem persists.
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Manufacturer Narrative
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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 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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Event Description
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The oticon medical representative reported the inability to communicate with the cochlear implant.Despite the antennas, magnets, cables and processors changes, the problem persists.
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Search Alerts/Recalls
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