FDA Adverse Event
Injury
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 9887247
·
Received March 27, 2020
Report
- Report Number
- 6000034-2020-00866
- Event Type
- Injury
- Date Received
- March 27, 2020
- Report Date
- April 1, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502007320
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THIS REPORT IS SUBMITTED ON APRIL 24, 2020.
Additional Manufacturer Narrative · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THIS REPORT IS SUBMITTED ON APRIL 24, 2020.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2020.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON APRIL 3, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MARCH 27, 2020.
Description of Event or Problem · 1
PER THE SURGEON, THE PATIENT EXPERIENCED SKIN BREAKDOWN RESULTING IN THE IMPLANT EXTRUDING. THE IMPLANT WAS SUCCESSFULLY RE-POSITIONED (DATE UNKNOWN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351853 | NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE (CA) | NA | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |