FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2220989
·
Received August 23, 2011
Report
- Report Number
- 6000034-2011-00627
- Event Type
- Injury
- Date Received
- August 23, 2011
- Date of Event
- August 4, 2011
- Report Date
- March 26, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, AFTER YEARS OF SUCCESSFUL DEVICE USE, THE PATIENT EXPERIENCED SWELLING IN THE AREA OF THE TRANSMITTING COIL AND THE PATIENT WAS HOSPITALIZED FOR TREATMENT OF "INFLAMMATION" (TYPE NOT REPORTED.) THE RECEIVER/STIMULATOR SUBSEQUENTLY BECAME EXPOSED AND THE DEVICE WAS EXPLANTED ON (B)(6), 2011. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(6), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Hospitalization| R |