FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22
MDR report key: 8485503
·
Received April 4, 2019
Report
- Report Number
- 6000034-2019-00458
- Event Type
- Injury
- Date Received
- April 4, 2019
- Date of Event
- December 7, 2018
- Report Date
- March 15, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P840024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON APRIL 05, 2019, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2018 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 275531 | NUCLEUS 22 | NUCLEUS 22 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI22M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |