FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3962543
·
Received June 30, 2014
Report
- Report Number
- 9710014-2014-00338
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- June 22, 2014
- Report Date
- June 24, 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 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 PARENT OF THE PATIENT HAS NOTICED A DECLINE IN THE PATIENT'S HEARING PERFORMANCE. THERE HAS BEEN NO REPORT OF TRAUMA. IN SITU MEASUREMENTS SHOW 9 CHANNELS WITH HIGH IMPEDANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378634 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | SONATA H STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |