FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2220978
·
Received August 23, 2011
Report
- Report Number
- 6000034-2011-00622
- Event Type
- Injury
- Date Received
- August 23, 2011
- Report Date
- January 9, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011; THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON (B)(6) 2011. THIS REPORT IS FILED JUNE 19, 2012.
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED A RECURRENT SKIN FLAP INFECTION WHICH WAS TREATED WITH ANTIBIOTICS (TYPE AND DATE NOT REPORTED). THE PATIENT SUBSEQUENTLY UNDERWENT AN INCISION AND DRAINAGE OF THE SITE, WHICH DID NOT ALLEVIATE THE PROBLEM. IT WAS REPORTED THAT THE IMPLANT IS EXPOSED. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24R (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |