FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE
MDR report key: 8576513
·
Received May 3, 2019
Report
- Report Number
- 6000034-2019-00670
- Event Type
- Injury
- Date Received
- May 3, 2019
- Date of Event
- April 10, 2019
- Report Date
- May 17, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502032612
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS FILED ON JUNE 05, 2019.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MAY 03, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE TIP OF THE ELECTRODE ARRAY WAS PARTIALLY INSERTED AND FOUND TO BE FOLDED OVER IN THE COCHLEA, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371676 | NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI532 | N/A | 09321502032612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |