Model Number CI-1500-04 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 08/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The recipient reportedly experienced a foreign body reaction around the incision site.The recipient reportedly underwent a temporalis muscle flap revision surgery.The recipient is reportedly doing well.
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Manufacturer Narrative
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The recipient's device was explanted.
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Manufacturer Narrative
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The external visual inspection revealed the electrode was severed prior to receipt as well as a cut on the silastic overmold of the antenna coil.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed damage on the antenna coil wire as well as a cut shield wire.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented one of the electrical tests from being performed.The device passed all of the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.
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Manufacturer Narrative
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(b)(4).Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain additional information regarding treatment were unsuccessful.The recipient is reportedly healed.This is the final report.
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Search Alerts/Recalls
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