FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3974703
·
Received August 4, 2014
Report
- Report Number
- 6000034-2014-01094
- Event Type
- Injury
- Date Received
- August 4, 2014
- Date of Event
- July 3, 2014
- Report Date
- August 12, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED AUGUST 15, 2014.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A HAEMORRHAGE IN THE RECOVERY ROOM ON (B)(6) 2014, SUBSEQUENT TO UNDERGOING INITIAL IMPLANT SURGERY. THE HAEMORRHAGE COULD NOT BE RESOLVED AND THE PATIENT WAS PLACED BACK INTO THE OPERATING ROOM TO EXPLANT THE DEVICE. A NEW DEVICE WAS IMPLANTED DURING THE SAME SURGERY ON (B)(6) 2014, AND THE SURGICAL WOUND WAS CLOSED WITHOUT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454490 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |