N
Patient 1
THIS REPORT IS FILED FEBRUARY 18, 2016. THE IMPLANTED DEVICE REMAINS.
MAUDE MDR 5448654
- MDR report key
- 5448654
- Report number
- 6000034-2016-00326
- Event key
- 0
- Event type
- 3
- Date received
- 2016-02-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 101
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. ANGEL WRIGHT
- Address
- 13059 EAST PEAKVIEW AVENUE CENTENNIAL CO 80111 US
- Phone
- 303-303-3037
- 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 AUDITORY BRAINSTEM IMPLANT SYSTEM | MCM | COCHLEAR LTD . | MHE | ABI541 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-02-19 | 0 | 1. R |
Event Narratives#
D
Patient 1
PER THE CLINIC, THE INTERNAL MAGNET BECAME DISLODGED FOR UNKNOWN REASONS. THE IMPLANTED DEVICE REMAINS.
N
Patient 1
PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 TO REPOSITION THE INTERNAL MAGNET. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED JULY 8, 2016.