Model Number ASKU |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
Additional information has been requested regarding the brand name and model number of the implanted device: this information has been made available as of the date of this report.Should further information be provided, a supplementary report shall be submitted.This report is submitted on december 30, 2019.
|
|
Event Description
|
Per the clinic, the patient experienced a magnet dislodgement during an mri (tesla strength unknown).The patient's head was not wrapped as recommended by cochlear.The device was explanted (date unknown) and the patient was reimplanted with a new device during the same surgery.
|
|
Manufacturer Narrative
|
Correction: this mdr was a duplicate.Any further information will be provided with report number 6000034-2020-00113.This report is submitted june 11, 2020.
|
|
Search Alerts/Recalls
|