FDA Adverse Event
Injury
Summary report: N
NUCLEUS HYBRID L24
MDR report key: 11795895
·
Received May 10, 2021
Report
- Report Number
- 6000034-2021-01311
- Event Type
- Injury
- Date Received
- May 10, 2021
- Date of Event
- April 1, 2021
- Report Date
- June 1, 2021
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- PGQ
- UDI-DI
- 09321502012089
- PMA / PMN Number
- P130016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON JUNE 24, 2021.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON 10 MAY 2021.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021. IT IS UNKNOWN IF THERE ARE 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 |
|---|---|---|---|---|---|---|---|
| 693229 | NUCLEUS HYBRID L24 | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM | PGQ | COCHLEAR LIMITED | CI24RE (L24) | NA | 09321502012089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |