FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN
MDR report key: 187681
·
Received September 18, 1998
Report
- Report Number
- 6000034-1998-00063
- Event Type
- Injury
- Date Received
- September 18, 1998
- Date of Event
- August 15, 1996
- Report Date
- September 18, 1998
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT COMPLAINED OF CHANGED SOUND QUALITY. AN X-RAY CONFIRMED THE ELECTRODE ARRAY HAD MIGRATED OUT OF THE COCHLEA. THE PT WAS EXPLANTED AND REIMPLANTED ON 8/15/1996. THE PT PERFORMS WELL WITH HER DEVICE. IS IS UNK WHY THIS NON-USA HEALTH CARE PROVIDER DID NOT REPORT THIS IMMEDIATELY. A REP FROM THE MFR WILL DISCUSS TIMELY REPORTING WITH THE HEALTHCARE PROFESSIONALS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN Implant | 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN | MCM | COCHLEAR LTD. | CI22M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |