FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
MDR report key: 10268923
·
Received July 14, 2020
Report
- Report Number
- 6000034-2020-01757
- Event Type
- Malfunction
- Date Received
- July 14, 2020
- Date of Event
- June 11, 2020
- Report Date
- March 2, 2021
- 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
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON 31 MAR 2021.
Additional Manufacturer Narrative · 0
IT IS NOW REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THIS REPORT IS SUBMITTED ON DECEMBER 14, 2020.
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JULY 14, 2020.
Description of Event or Problem · 1
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN DURING AN MRI SCAN (TESLA 1.5) WHICH WAS SUBSEQUENTLY TERMINATED. IT WAS REPORTED THAT THE PATIENT'S HEAD WAS WRAPPED PER THE MANUFACTURER'S GUIDELINES. A CT SCAN WAS PERFORMED AND CONFIRMED DISLODGMENT OF THE IMPLANT MAGNET. IT IS UNKNOWN IF THERE ARE PLAN FOR REVISION SURGERY TO CORRECT THE MAGNET PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735248 | 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 | 39 YR | Required Intervention |