N
Patient 1
THIS REPORT IS SUBMITTED ON 01 APRIL 2020.
MAUDE MDR 9908720
- MDR report key
- 9908720
- Report number
- 6000034-2020-00995
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-14
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. KRISTEL KOHNE
- 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 CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | COCHLEAR LTD | MCM | CI24RE (CA) | NA | NA | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN, NON-AUDITORY SENSATIONS AND POOR PERFORMANCE WITH DEVICE USE. SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2020. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THIS REPORT.