FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 2882117
·
Received December 18, 2012
Report
- Report Number
- 9710014-2012-00474
- Event Type
- Malfunction
- Date Received
- December 18, 2012
- Date of Event
- May 22, 2011
- Report Date
- December 12, 2012
- Manufacturer
- MED-EL ELEKTROMEDIZINISHCE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO 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 PT SUFFERED A HEAD TRAUMA. HE IS STILL ABLE TO HEAR BUT HIS PERFORMANCE HAS DECLINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | SONATA STANDARD | MCM | MED-EL ELEKTROMEDIZINISHCE GERAETE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |