FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3962561
·
Received June 30, 2014
Report
- Report Number
- 9710014-2014-00327
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- April 14, 2014
- Report Date
- June 18, 2014
- 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 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 THE ELECTRODE CHANNEL'S IMPEDANCES HAD BEEN INCREASING OVER TIME. HOWEVER THE PERFORMANCE WITH THE COCHLEAR IMPLANT HAS NOT DETERIORATED. AS PER ADDITIONAL INFORMATION RECEIVED, CT SCAN RESULTS REVEALED 5 ELECTRODE CHANNELS TO BE EXTRA-COCHLEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378856 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | MED-EL CONCERT + STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |