FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1771049
·
Received July 27, 2010
Report
- Report Number
- 6000034-2010-00482
- Event Type
- Injury
- Date Received
- July 27, 2010
- Date of Event
- June 29, 2010
- Report Date
- March 8, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 840024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B) (4)
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED (B)(6), 2011.
Description of Event or Problem · 1
PER THE CLINIC, ON (B) (4) 2007, THE PATIENT EXPERIENCED FACIAL NERVE STIMULATION AND FACIAL NERVE PARALYSIS. A VISIT TO THE EMERGENCY ROOM ON (B) (4) 2008 RESULTED IN THE DIAGNOSIS OF AN UNIDENTIFIED VIRUS. REPROGRAMMING THE DEVICE AFTER THE VIRUS RESOLVED ITSELF RESULTED IN SOME PERFORMANCE IMPROVEMENT. SUBSEQUENTLY, THE PATIENT DESIRED EXPLANTATION AND THE MANUFACTURER BECAME AWARE UPON RECEIPT OF THE EXPLANTED DEVICE ON (B) (4) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI22M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |