FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2231224
·
Received August 26, 2011
Report
- Report Number
- 9710014-2011-00261
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- April 1, 2011
- Report Date
- August 22, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 IN EARLY (B)(6) 2011, THE PATIENT REPORTED A SIGNIFICANT DECREASE IN SPEECH DISCRIMINATION AND PERCEPTION. AIDED TESTING INDICATED A SIGNIFICANT DECREASE (FROM 72% TO 20%) IN SPEECH DISCRIMINATION FOR THAT EAR. EXTERNALS WERE EXCHANGED; HOWEVER, NO IMPROVEMENT WAS OBSERVED. CT SCAN WAS COMPLETED AND REVEALED COMPLETE ELECTRODE INSERTION WITH NOTHING REMARKABLE NOTED.
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 | 69 YR | Required Intervention |