Device Problems
No Device Output (1435); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Hearing Impairment (1881)
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Event Date 03/16/2015 |
Event Type
Injury
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Event Description
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It was reported that the patient had not returned to the clinic for about 1 year.Patient's mother made an appointment because the patient had not been wearing the processor for a few months since her teachers said she cannot hear from it.There was no specific head trauma noted, although her mother did note that she suffered a significant seizure in (b)(6) and required hospitalization.
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Manufacturer Narrative
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Damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The problems given in the pt report appear to match the damage found.This is a final report.
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Event Description
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It was reported that the pt had not returned to the clinic for about 1 year.Pt's mother made an appointment because the pt had not been wearing the processor for a few months since her teachers said she cannot hear from it.There was no specific head trauma noted, although her mother did note that she suffered a significant seizure in november and required hospitalization.
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Search Alerts/Recalls
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