FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 1980221
·
Received February 1, 2011
Report
- Report Number
- 9710014-2011-00037
- Event Type
- Injury
- Date Received
- February 1, 2011
- Date of Event
- October 20, 2010
- Report Date
- February 1, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NO LONGER ANY COMMUNICATION WITH THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH | C40+ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |