FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3130637
·
Received May 24, 2013
Report
- Report Number
- 6000034-2013-00980
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- April 29, 2013
- Report Date
- May 24, 2013
- Manufacturer
- COCLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE IN (B)(6) 2009 (SPECIFIC DATE NOT REPORTED) FOR TYMPANOMASTOID OBLITERATION. THE IMPLANTED DEVICE REMAINS. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE IMPLANT ON (B)(6) 2009, WITH PERFORATION OF THE TYMPANIC MEMBRANE. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231289 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCLEAR LTD | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |