FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 8904523
·
Received August 18, 2019
Report
- Report Number
- 6000034-2019-01476
- Event Type
- Injury
- Date Received
- August 18, 2019
- Date of Event
- July 19, 2019
- Report Date
- October 15, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED OCTOBER 29, 2019. - ATTACHMENT: [151645 DEVICE ANALYSIS REPORT REG.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON AUGUST 19, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 698138 | 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 | 14 YR | Required Intervention |