FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3103363
·
Received May 9, 2013
Report
- Report Number
- 6000034-2013-00822
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- April 10, 2013
- Report Date
- September 2, 2013
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT FILED OCTOBER 10, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT SUSTAINED A HEAD INJURY WHICH DISPLACED BOTH OF HIS INTERNAL DEVICES (HE IS BILATERALLY IMPLANTED). DURING SURGERY TO REPOSITION THIS DEVICE, THE GROUND ELECTRODE WAS ACCIDENTALLY CUT. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203749 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD . | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 MO | Required Intervention |