FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2900902
·
Received January 2, 2013
Report
- Report Number
- 9710014-2012-00500
- Event Type
- Injury
- Date Received
- January 2, 2013
- Report Date
- December 28, 2012
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED. 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 PT HAD BEEN SATISFIED WITH THE PERFORMANCE UNTIL (B)(6) 2012. SINCE (B)(6) 2012, HE HAD BEEN EXPERIENCING LOUD NOISES WITH PAIN ON THE IMPLANT AREA. THIS WAS PRESENT WITH AND WITHOUT USING THE AUDIO PROCESSOR. THE CLINIC HAD NO EXPLANATION FOR THE PAIN. THE NOISE AND PAIN WERE NOT PRESENT ALL THE TIME, THEREFORE THE PT STILL HAD SOME BENEFIT WITH HIS CI. THE COIL MAGNET HAD BEEN REPLACED BY A STRONGER ONE, AS THE MAGNET STRENGTH HAD NOT BEEN SUFFICIENT ANYMORE. ON TOUCHING THE IMPLANTED AREA THE PT FELT PAIN. THE PT WAS RE-IMPLANTED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | PULSAR STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |