FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 3211212
·
Received July 8, 2013
Report
- Report Number
- 6000034-2013-01252
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN FLAP BREAKDOWN, RESULTING IN THE EXPOSURE OF THE RECEIVER/STIMULATOR UNIT. ON (B)(6) 2013, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE RECEIVER/STIMULATOR REPOSITIONED POSTERIORLY TO ITS ORIGINAL POSITION. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309837 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |