FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2061443
·
Received April 18, 2011
Report
- Report Number
- 6000034-2011-00265
- Event Type
- Injury
- Date Received
- April 18, 2011
- Date of Event
- March 24, 2011
- Report Date
- August 8, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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, THE DEVICE WAS EXPLANTED DUE TO ITS BECOMING EXPOSED SUBSEQUENT TO A HEAD TRAUMA. TWO REVISION SURGERIES (DATES NOT REPORTED) DID NOT RESOLVE THE ISSUE. THE DEVICE WAS EXPLANTED ON (B)(6) 2011. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE TIME 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. | CI24R (CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |