FDA Adverse Event
Injury
Summary report: N
COCHLEAR IMPLANT
MDR report key: 2221350
·
Received August 15, 2011
Report
- Report Number
- 2221350
- Event Type
- Injury
- Date Received
- August 15, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 12, 2011
- Manufacturer
- COCHLEAR AMERICAS
- Product Code
- MCM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
COCHLEAR IMPLANT INITIALLY IMPLANTED ON (B)(6) 2011. ACCORDING TO SURGEON, PT HAD NO POST-OP COMPLICATIONS. AFTER ACTIVATION OF THE PROCESSOR, DEVICE WORKED NORMALLY FOR ONE MONTH, AFTER WHICH IT SUDDENLY STOPPED WORKING. MFR REP COMPLETED AND ON-SITE VISIT AT THE PT'S HOME AND WHEN NO COMMUNICATION COULD BE OBTAINED FROM THE PROCESSOR, IT WAS DETERMINED TO BE DEVICE FAILURE. DEVICE WAS EXPLANTED ON (B)(6) 2011, AND WARRANTY REPLACEMENT DEVICE WAS IMPLANTED SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COCHLEAR IMPLANT | COCHLEAR IMPLANT | MCM | COCHLEAR AMERICAS | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |