Model Number CI-1400-01 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Pain (1994); Vertigo (2134); Total Hearing Loss (4473)
|
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing pain, vertigo, and non-auditory sensation with device use.The recipient is taking medication for the vertigo.Device testing revealed results within normal limits.External equipment was exchanged and the vertigo reduced.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
The recipient's issues reportedly resolved and the recipient is able to use the device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.Additional information regarding treatment details were not provided.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
|