FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 11008446
·
Received December 15, 2020
Report
- Report Number
- 6000034-2020-03440
- Event Type
- Malfunction
- Date Received
- December 15, 2020
- Date of Event
- November 27, 2020
- Report Date
- November 24, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032599
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON DECEMBER 15, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT DURING AN MRI (DATE AND TESLA STRENGTH UNKNOWN). SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED ON (B)(6) 2020. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1477901 | NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI522 | NA | 09321502032599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |