Model Number CI-1500-04 |
Device Problems
Device Dislodged or Dislocated (2923); Expulsion (2933); Appropriate Term/Code Not Available (3191)
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Patient Problems
Head Injury (1879); Insufficient Information (4580)
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Event Date 09/25/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced a displaced magnet following a mri.The recipient was advised to cease device use.The recipient's device was explanted during a magnet replacement surgery.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Appropriate bandaging protocol was reportedly not used during the mri.The external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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