N
Patient 1
THIS REPORT IS SUBMITTED ON MARCH 27, 2020.
MAUDE MDR 9887089
- MDR report key
- 9887089
- Report number
- 6000034-2020-00852
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | COCHLEAR LTD | MCM | CI512 | NA | NA | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 | 1. R |
Event Narratives#
D
Patient 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE FOLLOWING THE REMOVAL OF THE INTERNAL MAGNET PRIOR TO AN MRT. THE INFECTION WAS TREATED WITH ORAL ANTIBIOTIC. THE IMPLANT REMAINS IN-SITU.