FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 22686966
·
Received August 1, 2025
Report
- Report Number
- 6000034-2025-02754
- Event Type
- Injury
- Date Received
- August 1, 2025
- Date of Event
- July 8, 2025
- Report Date
- March 19, 2026
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- UDI-DI
- 09321502036818
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
DEVICE ANALYSIS REPORT.
Additional Manufacturer Narrative · 0
CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON JULY 08, 2025, WAS FILED INADVERTENTLY. THE CORRECT EXPLANT DATE WAS ON N(B)(6) 2025, NOT (B)(6) 2025. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Description of Event or Problem · 0
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2025. IT IS UNKNOWN IF THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414392 | NUCLEUS CI612 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | CI612 | NA | 09321502036818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |