FDA Adverse Event
Other
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYS
MDR report key: 3161853
·
Received June 5, 2013
Report
- Report Number
- 9710014-2013-00219
- Event Type
- Other
- Date Received
- June 5, 2013
- Report Date
- May 31, 2013
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S TEACHER HAD NOTICED THAT THE PT WAS NOT HEARING WELL IN (B)(6) 2013. THE PT IS BILATERALLY IMPLANTED AND THE RIGHT SIDE WAS IN QUESTION. SHE ATTENDED THE CLINIC FOR TESTING AND A CT SCAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249223 | MED-EL MAESTRO COCHLEAR IMPLANT SYS | MED-EL CONERT + COMPRESSED | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |