Model Number AB-5100R |
Device Problems
Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2022 |
Event Type
malfunction
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Event Description
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The company was informed that the patient¿s device will be electively explanted, despite the recipient not experiencing any issues with device.The patient will be reimplanted with another cochlear implant.Explant surgery is scheduled.
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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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The recipient's device was explanted.The recipient was reimplanted with another cochlear device.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.The recipient is reportedly doing well and performing well with the new device.The external visual inspection revealed that the electrode array was severed.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical test performed.This device was explanted for medical reasons.The device passed the tests performed.This older device configuration is no longer manufactured.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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