Model Number CI-1601-05 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
|
Patient Problems
Pain (1994); Tinnitus (2103); No Code Available (3191)
|
Event Date 06/26/2020 |
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing poor performance.The recipient is presenting with tinnitus, non-auditory sensations and pain with and without device use.The surgeon referred the recipient to neurology, and placed the recipient on bactrim proactively to treat any possible infection present.Recipient ceased device use.
|
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
The recipient's issues are reportedly not believed to be device related.The recipient resumed device use despite being recommended to cease device use.The recipient was given medication for the pain.The recipient is experiencing heat at the magnet site and a popping sensation.On (b)(6) 2020, the recipient received a post-auricular nerve block shot.Programming adjustments were made, however, the issue did not resolve.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
The recipient continues to experience pain, despite treatment.Revision surgery will be scheduled.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Additional information: sections b.3 & d.7 the recipient's device was reportedly explanted.The recipient will not be reimplanted at this time.The recipient has healed from surgery and the pain has resolved.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Correction: section b.3.Advanced bionics considers the investigation into this reportable event as closed.Additional treatment details will not be provided.The external visual inspection revealed the array 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 version of ultra is no longer distributed.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Search Alerts/Recalls
|