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 09/17/2015 |
Event Type
Injury
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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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Event Description
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Patient's access to sound with the device is affected at low frequencies.In situ testing has shown an increasing number of channels with high impedance since (b)(6) 2014.Latest in situ testing showed 8 channels with high impedance.An accident or trauma is not known.A ct scan showed normal results.
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Manufacturer Narrative
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Conclusion: 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 patient report appear to match the damage found.This is a final report.
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Event Description
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Patient's access to sound with the device was affected at low frequencies.In-situ testing showed an increasing number of channels with high impedance since (b)(6) 2014.Latest in-situ testing showed 8 channels with high impedance.
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Search Alerts/Recalls
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