FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 3042823
·
Received April 4, 2013
Report
- Report Number
- 9710014-2013-00119
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Date of Event
- December 27, 2011
- Report Date
- March 27, 2013
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN EXPLANTED. IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR 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 ON (B)(6) 2011 TESTING PERFORMED IN SITU SHOWED SOME ELECTRODE CHANNELS IN STATUS HI. AT THE PRESENT DAY, ALL ELECTRODE CHANNELS SHOWED STATUS HI. AUDITORY RESPONSE WAS CHECKED AND SEEMED TO BE OBTAINED ON ELECTRODE CHANNELS WITH STATUS HI. IT IS NOT KNOWN IF ANY IMPACT OCCURRED AT THE IMPLANT SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139236 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | PULSAR STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |