FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 2200237
·
Received August 11, 2011
Report
- Report Number
- 6000034-2011-00596
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- June 6, 2011
- Report Date
- July 29, 2011
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION NEAR THE IMPLANT SITE AND WAS TREATED WITH MEDICATION (TYPE NOT REPORTED), WHICH DID NOT ALLEVIATE THE PROBLEM. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2011 TO TREAT THE INFECTION. AFTER THE SURGERY THE PATIENT REPORTED A LACK OF AUDITORY PERCEPTS. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Required Intervention |