FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2517297
·
Received April 4, 2012
Report
- Report Number
- 6000034-2012-00616
- Event Type
- Injury
- Date Received
- April 4, 2012
- Date of Event
- March 14, 2012
- Report Date
- December 16, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON 07 FEB 2014.
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT DATE OF IMPLANT WAS (B)(6) 2006; NOT (B)(6) 2007 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED 10 FEB 2014.
Additional Manufacturer Narrative · 1
PER THE PATIENTS DEVICE RECORD, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE (B)(6) 2012. CORRECTION: THE CORRECT SERIAL NUMBER OF THE DEVICE IS (B)(4); NOT (B)(4) AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2012.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO INFECTION.THE DEVICE WAS EXPLANTED (B)(6), 2012. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |