FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2983067
·
Received February 28, 2013
Report
- Report Number
- 6000034-2013-00394
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- February 18, 2013
- Report Date
- October 3, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ON OCTOBER 3, 2013 INFORMATION WAS RECEIVED THAT THE EVENT REPORTED ON (B)(6) 2013 WAS IN FACT GENERATED UNDER A COMPUTER "TEST MODE" AND DID NOT IN FACT OCCUR. A REVIEW OF THE COMPLAINT AND ITS UPDATED INFORMATION HAS DETERMINED IT DOES NOT MEET THE DEFINITION FOR A FDA REPORTABLE EVENT, NOR FOR A COMPLAINT. THIS REPORT IS FILED OCTOBER 31, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED WARM SENSATION WITH EXTERNAL DEVICE USE RESULTING IN DISCOMFORT. NO SERIOUS INJURY HAS OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87680 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | SP12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 MO | Required Intervention |