FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 2182416
·
Received July 28, 2011
Report
- Report Number
- 6000034-2011-00543
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- April 1, 2011
- Report Date
- July 25, 2011
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT DURING AN MRI (1.5 TESLA). THE PATIENT'S HEAD WAS WRAPPED AS AN APPROVED INDICATION IN (B)(6). SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED (DATE NOT REPORTED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Required Intervention |