FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 8606588
·
Received May 14, 2019
Report
- Report Number
- 6000034-2019-00770
- Event Type
- Malfunction
- Date Received
- May 14, 2019
- Date of Event
- March 14, 2019
- Report Date
- May 31, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
ANALYSIS OF DEVICE INDICATES A DEVICE FAILURE. THIS REPORT IS FILED ON JUNE 25, 2019. - ATTACHMENT: [142356 DEVICE ANALYSIS REPORT.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MAY 14, 2019.
Description of Event or Problem · 1
AS PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO POOR HEARING PERFORMANCE. THE PATIENT WAS RE-IMPLANTED WITH ANOTHER DEVICE AT THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400471 | NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI512 | N/A | 09321502014564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| R |