FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 3830594
·
Received May 5, 2014
Report
- Report Number
- 9710014-2014-00209
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- February 1, 2014
- Report Date
- April 23, 2014
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO MED-EL HEADQUARTERS, WHERE IT WILL BE EVALUATED. 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 PATIENT WAS RE-IMPLANTED ON (B)(6) 2014, AND THE IMPLANT BODY NEARLY COMPLETELY COVERED BY TENSE NEW BONE FORMATION. AFTER DRILLING THE BONE, NO MEASUREMENTS COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268052 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | C40+ STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |