Model Number SONATA |
Device Problems
Device Operates Differently Than Expected (2913); Output below Specifications (3004)
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Patient Problems
Bruise/Contusion (1754); Fall (1848); Failure of Implant (1924); Loss of consciousness (2418)
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Event Type
Injury
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Event Description
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It was reported that the patient had no longer access to sound.Patient's parents reported that toward end of (b)(6) 2015 the patient had a fall and the implant ear got bruised.After this they noticed he was unresponsive.Previously the patient was showing progress in spoken language development.Re-implantation is considered.
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Manufacturer Narrative
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(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the mfr for evaluation.When available, a device failure analysis will be submitted as a f/u report.
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Manufacturer Narrative
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(b)(4).According to the currently available information, it appears the problems with the active electrode are most likely broken wires due to the reported accident.To determine an exact root cause a device investigation of the explanted device is necessary.The complaint will be reopened as and when the device is explanted.
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Event Description
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It was reported that the patient had no longer access to sound.Patient's parents reported that towards end of (b)(6) v2015 the patient had a fall and the implant ear got bruised.After this they noticed he was unresponsive.Previously the patient was showing progress in spoken language development.Re-implantation is considered but not scheduled yet.
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Manufacturer Narrative
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The investigation results confirmed that the device has failed due to an external impact to the active electrode.All the problems given in the patient report and the reported trauma appear to match well with this finding.This is a final report.
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Event Description
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It was reported that the patient no longer had access to sound.Patient_s parents reported that towards end of (b)(6) 2015 the patient had a fall and the implant ear got bruised.After this they noticed he was unresponsive.Previously the patient was showing progress in spoken language development.The patient has been re-implanted.
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Search Alerts/Recalls
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