FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2160242
·
Received July 13, 2011
Report
- Report Number
- 6000034-2011-00469
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 3, 2011
- Report Date
- August 9, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
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 A POST-AURICULAR ABSCESS AND INFECTION. ORAL ANTIBIOTICS (TYPE NOT REPORTED) WERE ADMINISTERED BUT THEY DID NOT RESOLVE THE PROBLEM. THE DEVICE WAS EXPLANTED ON (B)(6) 2011. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE.
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. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |