FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3321117
·
Received September 3, 2013
Report
- Report Number
- 6000034-2013-01595
- Event Type
- Injury
- Date Received
- September 3, 2013
- Date of Event
- June 13, 2013
- Report Date
- October 24, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED OCTOBER 25, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2013 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435811 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24R (CS) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |