FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2843518
·
Received November 19, 2012
Report
- Report Number
- 9710014-2012-00413
- Event Type
- Injury
- Date Received
- November 19, 2012
- Report Date
- November 12, 2012
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO INNSBRUCK 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
ACCORDING TO THE REPORT OF NOV 8 2012, THE PT WAS RE-IMPLANTED ON (B)(6) 2012. THE REASON FOR RE-IMPLANTATION WAS A TRAUMATIC DAMAGE OF THE DEVICE. CURRENTLY, NO FURTHER INFO HAS BECOME AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | PULSAR STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |