FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 5252553
·
Received November 26, 2015
Report
- Report Number
- 6000034-2015-02488
- Event Type
- Injury
- Date Received
- November 26, 2015
- Date of Event
- November 17, 2015
- Report Date
- April 5, 2016
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RECEIVED BY MANUFACTURER.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
AN UPDATED DEVICE ANALYSIS REPORT HAS NOW BEEN ATTACHED WITH ADDITIONAL ANALYSIS DETAILS. THIS REPORT IS FILED APRIL 27, 2016.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2015, DUE TO RECURRENT PAIN AT THE IMPLANT SITE. IT IS UNKNOWN IF THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782372 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |