FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2200242
·
Received August 11, 2011
Report
- Report Number
- 6000034-2011-00593
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- January 17, 2010
- Report Date
- March 26, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT DATE OF EXPLANT WAS (B)(6) 2011; NOT (B)(6) 2010 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(6) 2011.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED (B)(4), 2012.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AND A SUBSEQUENT EXTRUSION OF THE INTERNAL DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2010. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE 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. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |