Model Number AB-5100L |
Device Problems
Computer Software Problem (1112); No Apparent Adverse Event (3189)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2021 |
Event Type
malfunction
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Event Description
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The recipient reportedly elected revision surgery for a technology upgrade.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient was not re-implanted.The recipient's device was reportedly discarded and will not return to advanced bionics for analysis.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.A review of the device history record was completed and no anomalies were noted. 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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