FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1050261
·
Received May 22, 2008
Report
- Report Number
- 6000034-2008-00275
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- March 19, 2008
- Report Date
- May 22, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
REPORTEDLY, THE PATIENT WAS HIT IN THE HEAD OVER THE IMPLANT SITE AND THE INTERNAL MAGNET WAS DISPLACED FROM THE POCKET. THE PATIENT UNDERWENT A REVISION SURGERY (DATE NOT REPORTED) TO PLACE A NEW MAGNET INTO THE INTERNAL DEVICE MAGNET POCKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | COCHLEAR LTD. | CI24R(CS) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |