FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2092734
·
Received May 10, 2011
Report
- Report Number
- 9710014-2011-00152
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- January 31, 2011
- Report Date
- May 6, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- AUDIOLOGIST
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 F/U REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS RE-IMPLANTED ON (B)(6) 2011 AS THE DEVICE HAD MALFUNCTIONED. TO DATE NO ADDITIONAL INFORMATION HAS BEEN REC'D REGARDING THE REASON THE DEVICE HAD MALFUNCTIONED, LEADING TO RE-IMPLANTATION.
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 | C40+ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |