FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 2844620
·
Received November 12, 2012
Report
- Report Number
- 9710014-2012-00409
- Event Type
- Malfunction
- Date Received
- November 12, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- 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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT IS NOT ABLE TO HEAR. TESTING IN SITU SHOWED 7 CHANNELS IN STATUS HI AND 4 CHANNELS IN STATUS S/C. AN XRAY WAS TAKEN ON (B)(6) 2012 AND SHOWED THAT ALL ELECTRODES ARE IN THE COCHLEA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | SONATA STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |