FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2150468
·
Received June 7, 2011
Report
- Report Number
- 9710014-2011-00177
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 6, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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 EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S HEARING PERFORMANCE HAS DETERIORATED, AND THAT HER SPEECH DISCRIMINATION HAS DECREASED BY APPROX 40% COMPARED TO 6 MONTHS BEFORE. AN ACCIDENT HAS NOT REPORTED. TESTING CARRIED OUT ON (B)(6), 2011 SHOWS ELECTRODE CHANNELS 5, 7, 8, 9, 10, 11 AND 12 IN STATUS HI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH | SONATA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |