Model Number CI422 |
Device Problems
Device Dislodged or Dislocated (2923); Expulsion (2933)
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Patient Problems
Unspecified Infection (1930); Tissue Breakdown (2681)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on april 25, 2023.
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Event Description
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Per the clinic, the patient experienced an infection at the implant site, resulting in extrusion of the receiver / stimulator.Subsequently, the patient was treated with antibiotics (specific date, duration and type not reported).The implanted device remains.
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Manufacturer Narrative
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Per the clinic, the device was explanted on (b)(6) 2023 due to magnet dislocation.The patient was reimplanted with another cochlear device during the same surgery.This report is submitted on july 18, 2023.
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Manufacturer Narrative
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Device analysis report attached.This report is submitted on (b)(6), 2023.
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Search Alerts/Recalls
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