FDA Adverse Event
Injury
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 6390344
·
Received March 8, 2017
Report
- Report Number
- 6000034-2017-00509
- Event Type
- Injury
- Date Received
- March 8, 2017
- Date of Event
- February 27, 2017
- Report Date
- April 4, 2017
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON MARCH 09, 2017, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.
Description of Event or Problem · 0
PER THE CLINIC THE PATIENT EXPERIENCED PAIN WITH DEVICE USE RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2017. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT MARCH 09, 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170986 | NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE(CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |