FDA Adverse Event
Injury
Summary report: N
NUCLEUS HYBRID L24
MDR report key: 12089701
·
Received June 29, 2021
Report
- Report Number
- 6000034-2021-01864
- Event Type
- Injury
- Date Received
- June 29, 2021
- Date of Event
- June 1, 2021
- Report Date
- July 2, 2021
- Manufacturer
- COCHLEAR LTD
- Product Code
- PGQ
- UDI-DI
- 09321502012089
- PMA / PMN Number
- P130016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON JULY 21, 2021.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JUNE 30, 2021.
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2021, DUE TO IMPROPER PLACEMENT OF THE ELECTRODE ARRAY. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON THE SAME DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 985695 | NUCLEUS HYBRID L24 | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM | PGQ | COCHLEAR LTD | CI24RE (L24) | NA | 09321502012089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |