FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1982520
·
Received February 9, 2011
Report
- Report Number
- 6000034-2011-00066
- Event Type
- Injury
- Date Received
- February 9, 2011
- Date of Event
- November 23, 2010
- Report Date
- April 20, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- AUDIOLOGIST
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 ON (B)(6), 2011 DUE TO AN INFECTION AT THE IMPLANT SITE. THE INFECTION WAS TREATED WITH IV ANTIBIOTICS AS WELL AS A SURGICAL DEBRIDEMENT ON (B)(6), 2010, BUT THESE DID NOT ALLEVIATE THE PROBLEM. A FLAP REVISION SURGERY (DATE NOT SPECIFIED) OCCURRED IN (B)(6), 2010. THE DEVICE WAS EXPLANTED ON (B)(6), 2011. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE 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. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |