FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1213517
·
Received October 27, 2008
Report
- Report Number
- 6000034-2008-00601
- Event Type
- Injury
- Date Received
- October 27, 2008
- Date of Event
- August 29, 2008
- Report Date
- October 9, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 9770051
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, IN 2008, THE PATIENT SUDDENLY HAD NO RESPONSE TO SOUND. EXCHANGING THE EXTERNAL EQUIPMENT DID NOT SOLVE THE PROBLEM. RESULTS OF AN INTEGRITY TEST DONE ON THE FOLLOWING MONTH WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION. AN X-RAY CONFIRMED THAT THE INTERNAL MAGNET HAD MOVED OUT OF THE POCKET. REVISION SURGERY WAS DONE ON THE NEXT DAY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD. | CI24R(CA) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |