FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2974014
·
Received May 16, 2008
Report
- Report Number
- 9710014-2008-00153
- Event Type
- Malfunction
- Date Received
- May 16, 2008
- Date of Event
- January 1, 2008
- Report Date
- May 2, 2008
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVAL. 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 ATTENDED THE HOSPITAL TO SEE THE CLINICAL ENGINEER, AS OVER THE PAST FEW MONTHS HER PARENTS HAVE NOTICED A LOSS OF QUALITY IN HER HEARING. TESTING SHOWED A PROGRESSIVE DAMAGE OF THE ELECTRODE ARRAY. AT LEAST 4 ELECTRODES HAVE A HI VALUE BUT 5 ELECTRODES ARE MARKED OK WITH THE ¿GREATER THAN¿ SYMBOL AND VERY HIGH IMPEDANCE VALUES. THE PATIENT¿S SYMPTOMS SEEM TO BE RELATED TO PROGRESSIVE ELECTRODE ARRAY DAMAGE DUE TO A MECHANICAL STRESS.
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 | 15 YR |