FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
MDR report key: 10287474
·
Received July 17, 2020
Report
- Report Number
- 6000034-2020-01819
- Event Type
- Injury
- Date Received
- July 17, 2020
- Date of Event
- April 28, 2020
- Report Date
- July 31, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502036573
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED AUGUST 25, 2020. ATTACHMENT: [173934 DEVICE ANALYSIS REPORT V2 REG.PDF]
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 17, 2020.
Description of Event or Problem · 1
PER THE SURGEON, THE DEVICE WAS INCORRECTLY PLACED AT THE TIME OF THE INITIAL IMPLANTATION. THE DEVICE WAS EXPLANTED ON (B)(6) 2020. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756419 | NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI622 | N/A | 09321502036573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 MO | Required Intervention |