N
Patient 1
(B)(4).
MAUDE MDR 8614131
- MDR report key
- 8614131
- Report number
- 6000034-2019-00871
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-07-31
- Date received
- 2019-05-15
- 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
- MR. YI FENG
- Address
- 1 UNIVERSITY AVENUE MACQAURIE 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 24 ABI | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM | COCHLEAR LTD | MHE | ABI24M | N/A | N/A | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-15 | 0 | 1. R |
Event Narratives#
D
Patient 1
PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REIMPLANTATION HAS BEEN SCHEDULED; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT.