FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 10107392
·
Received June 1, 2020
Report
- Report Number
- 6000034-2020-01399
- Event Type
- Malfunction
- Date Received
- June 1, 2020
- Report Date
- July 28, 2020
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502014564
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED 19 AUGUST 2020. ATTACHMENT: [163542-DEVICE ANALYSIS REPORT.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON 2 JUNE 2020.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE SUBSEQUENT TO SUSTAINING A HEAD INJURY. THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND THE PATIENT WAS RE-IMPLANT WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571266 | NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI512 | NA | 09321502014564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |