FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1233908
·
Received November 13, 2008
Report
- Report Number
- 6000034-2008-00649
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 15, 2008
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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
PER THE AUDIOLOGIST, THE PATIENT'S DEVICE EXTRUDED 18 MONTHS AFTER IMPLANTATION DUE TO SKIN FLAP NECROSIS. THE PATIENT'S DEVICE WAS EXPLANTED IN 2008. REIMPLANT SURGERY IS PLANNED, BUT HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD. | CI24R(CS) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |