FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYS
MDR report key: 4190175
·
Received October 17, 2014
Report
- Report Number
- 9710014-2014-00545
- Event Type
- Malfunction
- Date Received
- October 17, 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 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 SUDDENLY LOST ACCESS TO SOUND WITH THE DEVICE AT THE END OF (B)(6) 2014, AND THAT ACCESS TO SOUND THEN RETURNED UNTIL (B)(6) 2014, WHEN THE PT COULD NO LONGER HAVE ACCESS TO SOUND WITH THE DEVICE. THERE WAS NO REPORT OF ILLNESS OR TRAUMA. RE-IMPLANTATION IS BEING CONSIDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662359 | MED-EL MAESTRO COCHLEAR IMPLANT SYS | SONATA | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |