|
Model Number CI422 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Nausea (1970); Vomiting (2144); Dizziness (2194)
|
Event Type
Injury
|
Manufacturer Narrative
|
This report is filed, january 18, 2016.The implanted device remains.
|
|
Event Description
|
Per the clinic, the patient experiences dizziness, nausea, and vomiting.Imaging (type and date not reported) revealed the electrode array migration through the canal wall.The implanted device remains.
|
|
Manufacturer Narrative
|
Per the clinic, the patient underwent revision surgery on (b)(6) 2016 to close the dehiscence in the right external auditory canal.The implanted device remains.This report is filed june 23, 2016.The implanted device remains.
|
|
Search Alerts/Recalls
|
|
|