Model Number PULSAR |
Device Problems
Impedance Problem (2950); Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Type
malfunction
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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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Information was received in correspondence from clinical support that some channels are affected by wire breakages.Reportedly the problems with high channels started back in 2017.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However, to determine an exact root cause a device investigation of the explanted device is necessary.Reportedly the recipient does not want to go for re-implantation surgery.
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Event Description
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Information was received in correspondence from clinical support that some channels are affected by wire breakages.Clinical support have suggested a revision surgery, but the user does not want to undergo this procedure.
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Search Alerts/Recalls
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