FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 10274391
·
Received July 15, 2020
Report
- Report Number
- 6000034-2020-01807
- Event Type
- Injury
- Date Received
- July 15, 2020
- Date of Event
- June 12, 2020
- Report Date
- June 22, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032599
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 15, 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020, TO REPOSITION THE RECEIVER STIMULATOR DUE TO MIGRATION OF THE DEVICE. THE IMPLANTED DEVICE REMAINS INSITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743086 | 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 | 64 YR | Required Intervention |