FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 1122353
·
Received August 18, 2008
Report
- Report Number
- 9710014-2008-00261
- Event Type
- Malfunction
- Date Received
- August 18, 2008
- Date of Event
- July 31, 2008
- Report Date
- August 7, 2008
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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 MANUFACTURER 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 AT THE PATIENT'S INITIAL ACTIVATION A SHORT CIRCUIT BETWEEN CHANNELS 3 AND 6, WHICH WAS DETECTED DURING INTRAOPERATIVE TESTING, WAS STILL PRESENT. THE SHORT CIRCUIT CHANNELS WERE GLOBALLY DE-ACTIVATED AND CHANNELS 10-12 WERE GLOBALLY DE-ACTIVATED DUE TO LACK OF AUDITORY PERCEPTION, LOUDNESS GROWTH AND SLIGHT FACIAL STIMULATION. ELECTRODES 10-12 ARE MOST LIKELY EXTRA-COCHLEAR. PATIENT PERFORMS APPEARS ADEQUATE. THE PATIENT WILL RETURN IN A WEEK FOR FOLLOW-UP.
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 | SONATA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |