FDA Adverse Event
Injury
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 7803676
·
Received August 21, 2018
Report
- Report Number
- 6000034-2018-01728
- Event Type
- Injury
- Date Received
- August 21, 2018
- Report Date
- October 16, 2018
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON AUGUST 22, 2018, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON OCTOBER 22, 2018. -(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642671 | 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 | Required Intervention |