FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 3131189
·
Received May 22, 2013
Report
- Report Number
- 9710014-2013-00201
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 17, 2013
- 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 THE CLINIC CONTACTED MED-EL AFTER PT ATTENDED A REVIEW AND HAD REDUCED PERFORMANCE. THERE IS NO REPORT OF ANY TRAUMA, ILLNESS OR INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227512 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | PULSAR STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |