Model Number PULSAR |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device has been explanted and should 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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Event Description
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In (b)(6) 2017 the patient's hearing with the device became suddenly worse.There is no reported trauma to the head.The patient was re-programmed and monitored by the clinic, but hearing performance did not improve.The patient was re-implanted on (b)(6) 2017.
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Manufacturer Narrative
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Conclusion: damage to the active electrode likely caused by minute device mobility was determined to have led to device failure over time.The investigation results appear to match the symptoms mentioned in the recipient report.This is a final report.
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Event Description
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In (b)(6) the recipient's hearing with the device became suddenly worse.There is no reported trauma to the head and external devices were checked.The recipient was re-programmed and monitored by the clinic, but hearing performance did not improve.The recipient was re-implanted.
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Search Alerts/Recalls
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