FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CONTOUR ADVANCE
MDR report key: 15631952
·
Received October 19, 2022
Report
- Report Number
- 6000034-2022-03109
- Event Type
- Injury
- Date Received
- October 19, 2022
- Report Date
- October 19, 2022
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON OCTOBER 19, 2022.
Additional Manufacturer Narrative · 0
CORRECTION: THE PREVIOUS MDR SUBMITTED ON OCTOBER 19, 2022 WAS FILED INADVERTENTLY. NO EXPLANTATION OR SERIOUS INJURY HAS OCCURRED. THIS REPORT IS SUBMITTED ON NOVEMBER 09, 2022.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2933193 | NUCLEUS 24 CONTOUR ADVANCE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | CI24R (CA) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |