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 Date 12/10/2017 |
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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The patient stopped responding to sound with the device after a reported head trauma.No swelling was noted at the implant site.Re-implantation is being planned.
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Manufacturer Narrative
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Additional information: based on information and measurements received, a mechanical damage to the stimulator housing which is typical for a severe external impact to the housing appears likely.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Re-implantation is being considered, but no surgery date has been communicated.
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Event Description
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The recipient stopped responding to sound with the device after a reported head trauma.No swelling was noted at the implant site.Re-implantation is being planned.
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Manufacturer Narrative
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Conclusion: the device investigation revealed mechanical damage to the stimulator housing and electronics that is typical for severe external impact to the housing.The problems described in the recipient report and the reported accident appears to match the damage found.This is a final report.
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Event Description
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The recipient stopped responding to sound with the device after a reported head trauma.No swelling was noted at the implant site.The recipient was re-implanted.
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Search Alerts/Recalls
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