FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1946002
·
Received January 4, 2011
Report
- Report Number
- 6000034-2010-00820
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- January 19, 2010
- Report Date
- August 9, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VE
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE CORRECT DATE OF SURGERY IS (B)(6), 2010 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4), 2011.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO AN INFECTION AND SUBSEQUENT EXPOSURE OF THE RECEIVER/STIMULATOR. ANTIBIOTICS (TYPE NOT REPORTED) AND WOUND TREATMENT DID NOT RESOLVE THE ISSUE. THE DEVICE WAS EXPLANTED ON (B)(6), 2010. THERE ARE NO PLANS TO REIMPLANT THE PATIENT 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 | 5 YR | Required Intervention |