Model Number PULSAR |
Device Problems
Device Operates Differently Than Expected (2913); Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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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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The recipient reported decreased hearing performance.There is a report of an accident or trauma.Re-implantation was performed on (b)(6) 2018.
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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.In addition, 3 channels had migrated out of cochlea.The problems given in the recipient report appear to match the damage found.This is a final report.
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Event Description
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Reportedly, the recipient had a decrease in hearing performance with the device.The recipient was re-implanted.
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Search Alerts/Recalls
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