FDA Adverse Event
Malfunction
Summary report: N
VIBRANT SOUNDBRIDGE
MDR report key: 1547208
·
Received November 26, 2009
Report
- Report Number
- 3004230826-2009-00058
- Event Type
- Malfunction
- Date Received
- November 26, 2009
- Date of Event
- October 1, 2009
- Report Date
- November 25, 2009
- Manufacturer
- VIBRANT MED-EL HEARING TECHNOLOGY GMBH
- Product Code
- MPV
- PMA / PMN Number
- P990052
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- AUDIOLOGIST
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. THIS DEVICE HAS BEEN MANUFACTURED BY SYMPHONIX CORP. VIBRANT MED-EL TOOK OVER THE ASSETS FROM SYMPHONIX CORP IN 2003. AS SUCH VIBRANT MED-EL FEELS RESPONSIBLE TO FOLLOW-UP ON PRODUCT PROBLEMS WITH SYMPHONIX PRODUCED DEVICES.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT THAT THE DEVICE TURNS ON AND OFF WHEN HE MOVES HIS JAW. THIS HAS BEEN PERSISTENT FOR A FEW WEEKS. THERE IS NO HISTORY OF ILLNESS OR ACCIDENT/HEAD TRAUMA THAT CAUSED THIS OR THAT OCCURRED PRIOR TO THE COMPLAINT. SOUND QUALITY IS OK. PT WILL BE SCHEDULED FOR AN X-RAY OR SCAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIBRANT SOUNDBRIDGE | MIDDLE EAR IMPLANT | MPV | VIBRANT MED-EL HEARING TECHNOLOGY GMBH | VORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |