FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2181188
·
Received July 8, 2011
Report
- Report Number
- 9710014-2011-00212
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 1, 2011
- Report Date
- July 5, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 AT THE END OF (B)(6), THE PT, WHO IS A BILATERAL USER, WAS WEARING HIS RIGHT PROCESSOR ONLY AND HIS MOTHER NOTICED HE WAS NOT HEARING ANYTHING. SHE THEN TURNED HIS LEFT PROCESSOR ON AND HE SEEMED TO BE HEARING FINE. SHE THEREFORE, CONTACTED THE CLINIC AND A REPLACEMENT PROCESSOR WAS SENT OUT FOR THE RIGHT EAR. HOWEVER, THIS MADE NO DIFFERENCE AND THE PT WAS SEEN AT THE CLINIC ON (B)(6) 2011, FOR A CHECKUP. TESTING SHOWED THAT THE DEVICE HAS MALFUNCTIONED.
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 | 3 YR |