FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 1513306
·
Received September 4, 2009
Report
- Report Number
- 9710014-2009-00326
- Event Type
- Malfunction
- Date Received
- September 4, 2009
- Report Date
- August 31, 2009
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 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 AN INCREASING NUMBER OF CHANNELS BECAME HI. LATEST TESTING CARRIED OUT ON (B) (6) 2009 SHOWED, THAT THE CHANNELS 1, 2, 6, 11 AND 12 HAVE THE STATUS HI. SOMETIMES IN THE PAST, CHANNEL 3 HAD THE STATUS HI. ANY INFLUENCE ON THE SPEECH COMPREHENSION CAN NOT BE CHECKED, AS THE PT IS VERY YOUNG AND HAS ONLY LITTLE ABILITY TO SPEAK UP TO NOW.
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 | PULSAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |