FDA Adverse Event
Injury
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 12502990
·
Received September 20, 2021
Report
- Report Number
- 6000034-2021-02827
- Event Type
- Injury
- Date Received
- September 20, 2021
- Report Date
- September 24, 2021
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE REPORT IS SUBMITTED ON OCTOBER 21, 2021.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON SEP 21, 2021.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH IV ANTIBIOTICS (DATE AND DURATION NOT REPORTED). HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2021. THERE ARE NO PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1400548 | NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | CI24RE (CA) | NA | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |