Model Number SONATA |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Idioventricular Rhythm (1923)
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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 has no longer a benefit from the device.No information is available concerning the possibility of trauma.Re-implantation is considered.
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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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The patient no longer has any benefit from the device.No information is available concerning the possibility of trauma.
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Search Alerts/Recalls
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