FDA Adverse Event
Injury
Summary report: N
NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 6423434
·
Received March 22, 2017
Report
- Report Number
- 6000034-2017-00629
- Event Type
- Injury
- Date Received
- March 22, 2017
- Date of Event
- October 26, 2016
- Report Date
- May 2, 2017
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- UDI-DI
- 09321502007320
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON MAY 22, 2017.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON MARCH 22, 2017.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND A PERFORMANCE DECREMENT WITH DEVICE USE, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6) 2016, 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 |
|---|---|---|---|---|---|---|---|
| 206643 | NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24RE (CA) | N/A | 09321502007320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |