Model Number MI1000 MED-EL CONCERT PIN |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not been explanted.If it should be explanted, it is to be returned to the mfr for eval.When available, a device failure analysis will be submitted as a f/u report.
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Event Description
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It was reported that in situ testing showed an increasing number of channels involved in short circuits through time.Latest in situ testing showed 6 electrode channels with status sc.An accident or trauma is not known.Re-implantation is being considered.
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Manufacturer Narrative
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Conclusion: during device investigation only one short circuit (between 9 and 12) out of reported three could be replicated.This is most likely due to the fact that the location of wires was shifted during the explantation, and for that reason not all short circuits could be detected.Possible causes to be considered for the observed short circuit include a technical defect of the active electrode as well as external mechanical influences.This is a final report.
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Event Description
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In situ testing showed an increasing number of channels involved in short circuits through time.Latest in situ testing showed 6 electrode channels involved in short circuits.An accident or trauma is not known.The patient has been re-implanted.
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Manufacturer Narrative
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Patient code and conclusion code were incorrect and has been amended.
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Event Description
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In situ testing showed an increasing number of channels involved in short circuits through time.Latest in situ testing showed 6 electrode channels involved in short circuits.An accident or trauma is not known.The patient has been re-implanted.
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Search Alerts/Recalls
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