FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3162012
·
Received June 5, 2013
Report
- Report Number
- 9710014-2013-00214
- Event Type
- Malfunction
- Date Received
- June 5, 2013
- Date of Event
- April 20, 2013
- Report Date
- May 28, 2013
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 A DECLINE IN THE PATIENT'S HEARING PERFORMANCE HAS BEEN NOTICED BY THE GUARDIANS SINCE (B)(6), 2013. A HISTORY OF A HEAD TRAUMA WAS DENIED BY THE GUARDIANS. PROBLEMS OF THE EXTERNAL DEVICES WERE EXCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249302 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | SONATA STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |