FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3873114
·
Received June 13, 2014
Report
- Report Number
- 6000034-2014-00849
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- May 28, 2014
- Report Date
- August 14, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2014; DURING THE SAME SURGERY, THE PATIENT WAS RE IMPLANTED WITH A NEW DEVICE. THIS REPORT IS FILED FEBRUARY 11, 2015.
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, NO CONNECTION COULD BE MADE TO THE INTERNAL DEVICE, AND THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349505 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE | MCM | COCHLEAR LTD. | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |