FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 3213951
·
Received July 3, 2013
Report
- Report Number
- 9710014-2013-00275
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- June 25, 2013
- Report Date
- July 1, 2013
- 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 HAD BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FELLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD NO HEARING PERCEPTION AND THAT THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE TO THIS DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303526 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | C40+ STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |