FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYS
MDR report key: 4190154
·
Received October 17, 2014
Report
- Report Number
- 9710014-2014-00541
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Date of Event
- September 27, 2014
- Report Date
- October 16, 2014
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- 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 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 HAD STOPPED BEING ABLE TO HEAR WITH THE DEVICE. THERE IS NO REPORT OF A TRAUMA OR ACCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661312 | MED-EL MAESTRO COCHLEAR IMPLANT SYS | SONATA | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |