FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 ABI
MDR report key: 9625069
·
Received January 23, 2020
Report
- Report Number
- 6000034-2020-00276
- Event Type
- Injury
- Date Received
- January 23, 2020
- Date of Event
- August 28, 2018
- Report Date
- February 18, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502002325
- PMA / PMN Number
- P000015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON MARCH 14, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON 24 JANUARY 2020.
Description of Event or Problem · 1
PER THE PATIENT'S SURGEON, THE PATIENT EXPERIENCED PAIN AND NON-AUDITORY SENSATIONS WITH DEVICE USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83933 | NUCLEUS 24 ABI | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | ABI24M | N/A | 09321502002325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |