Model Number MI1260 SONATA 2 |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Type
malfunction
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Event Description
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In situ testing showed affected channels.Further proceedings are unknown.
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it 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 situ testing showed affected channels.Further proceedings are unknown.
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Manufacturer Narrative
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Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.No information on possible further steps has been received.
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Search Alerts/Recalls
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