D
Patient 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2020, DUE TO A PERFORMANCE DECREMENT WITH DEVICE USE. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.
MAUDE MDR 9908602
- MDR report key
- 9908602
- Report number
- 6000034-2020-00912
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-13
- Date received
- 2020-03-31
- 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
- D
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 22 | NUCLEUS 22 COCHLEAR IMPLANT SYSTEM | COCHLEAR LTD | MCM | CI22M | NA | NA | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |