FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 3072395
·
Received April 19, 2013
Report
- Report Number
- 9710014-2013-00144
- Event Type
- Injury
- Date Received
- April 19, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 12, 2016
- 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
- Health Professional
- N
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 THE PATIENT WAS NOT ABLE TO HEAR ANYMORE. THE PATIENT WAS RE-IMPLANTED ON (B)(6), 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168883 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH | PULSAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Female | Required Intervention |