FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 4100445
·
Received September 19, 2014
Report
- Report Number
- 6000034-2014-01381
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- June 10, 2014
- Report Date
- August 28, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANT SITE AND UNDERWENT A REVISION SURGERY ON (B)(6) 2014. THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2014, TO REPOSITION THE RECEIVER/STIMULATOR UNIT DUE TO SKIN FLAP BREAKDOWN AND SUBSEQUENTLY EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585181 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24R (CS) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |