FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 19747990
·
Received July 16, 2024
Report
- Report Number
- 6000034-2024-02460
- Event Type
- Malfunction
- Date Received
- July 16, 2024
- Date of Event
- June 18, 2024
- Report Date
- September 12, 2024
- Manufacturer
- COCHLEAR LIMITED
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
DEVICE ANALYSIS INDICATED DEVICE FAILURE. DEVICE ANALYSIS REPORT ATTACHED.
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON JULY 16, 2024.
Description of Event or Problem · 0
PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2024, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2506806 | NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LIMITED | CI24RE (CA) | NA | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | Required Intervention |