FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+COCHLEAR IMPLANT SYSTEM
MDR report key: 3830556
·
Received May 5, 2014
Report
- Report Number
- 9710014-2014-00205
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- April 18, 2014
- Report Date
- April 22, 2014
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OBVIOUS DECLINE IN THE PATIENT'S HEARING PERFORMANCE WAS NOTICED BY THE GUARDIANS ON (B)(6) 2014. A HISTORY OF HEAD TRAUMA WAS DENIED BY THE GUARDIANS. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267379 | MED-EL COMBI 40+COCHLEAR IMPLANT SYSTEM | C40+ | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |