FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 3203603
·
Received July 3, 2013
Report
- Report Number
- 6000034-2013-01166
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- May 20, 2013
- Report Date
- June 21, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 COIL RETENTION ISSUES. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO THIN THE SKIN FLAP ON (B)(6), 2013. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304249 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24R (CS) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |