N
Patient 1
THIS REPORT IS SUBMITTED ON APRIL 1, 2020.
MAUDE MDR 9908248
- MDR report key
- 9908248
- Report number
- 6000034-2020-00924
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS BIANCA PRIES
- Address
- 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS
- 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 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | COCHLEAR LTD | MCM | CI532 | NA | NA | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) DUE TO POOR PERFORMANCE WITH DEVICE USE. IT IS UNKNOWN WHETHER THE PATIENT WAS IMPLANTED WITH ANOTHER DEVICE, AS OF THE DATE OF THIS REPORT.