FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 1963508
·
Received December 20, 2010
Report
- Report Number
- 9710014-2010-00407
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Date of Event
- December 10, 2010
- Report Date
- December 16, 2010
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- AUDIOLOGIST
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 PATIENT REFERS NO HEARING SENSATION. TESTING CARRIED OUT ON (B)(6) 2010, SHOWED 6 ELECTRODES WITH STATUS HI. PREVIOUS TESTING CARRIED OUT ON (B)(6) 2008, SHOWED STATUS OK FOR ALL ELECTRODES AND THE PT COULD DETECT AND DISCRIMINATE AT THIS MOMENT. NO REPORT OF TRAUMA. IT WAS FURTHER REPORTED THAT ON (B)(6) 2010, THE PT FELT UNCOMFORTABLE AND TOOK OFF THE SPEECH PROCESSOR.
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 | 6 YR |