Model Number 93550 |
Device Problems
No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/11/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
This report is submitted on september 27, 2023.
|
|
Event Description
|
Per the clinic, the patient experienced a progression in hearing loss resulting in loss of benefit.Subsequently, the implant magnet was explanted on (b)(6) 2023 under monitored anesthesia care.Re-implantation is planned but has not taken place as of the date of this report.
|
|
Manufacturer Narrative
|
Correction: this mdr was a duplicate.Any further information will be provided with report number 6000034-2023-01691.This report is submitted on october 12, 2023.
|
|
Search Alerts/Recalls
|