Model Number MI1000 MED-EL CONCERT |
Device Problems
High impedance (1291); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)
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Patient Problems
Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has 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 the bilaterally implanted pt bumped his head a few days ago adn sustained a slight swelling and cut to head near package bed on the left side.The swelling resolved with no sign of infection.The external parts were checked and found to be working.In situ measurements for the left implant revealed 11 electrode channels with status hi.The right sided implant was reported as unaffected with measurement results within normal limits.
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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.However, the location of the wire fractures, which were suspected to be caused by the reported external impact, could not be located, due to the damaged condition of the electrode lead.This is a final report.
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Event Description
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It was reported that the bilaterally implanted patient bumped his head a few days ago and sustained a slight swelling and cut to head near package bed on the left side.The swelling resolved with no sign of infection.The external parts were checked and found to be working.In-situ measurements for the left implant revealed 11 electrode channels with status hi.The right sided implant was reported as unaffected with measurement results within normal limits.
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Search Alerts/Recalls
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