FDA Adverse Event
Malfunction
Summary report: N
VIBRANT SOUNDBRIDGE
MDR report key: 1842280
·
Received August 27, 2010
Report
- Report Number
- 3004230826-2010-00038
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Report Date
- August 20, 2010
- Manufacturer
- VIBRANT MED-EL HEARING TECHNOLOGY GMBH
- Product Code
- MPV
- PMA / PMN Number
- P990052
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 F/U REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOR APPROX TWO WEEKS, THE PT NO LONGER HAS ANY HEARING SENSATION. ALLEGEDLY, IT STOPPED AFTER A BATTERY CHANGE. THE AUDIO PROCESSOR WAS CHECKED AND IT WORKS PROPERLY. WHEN THE IMPLANT WAS CHECKED, NO RTF-SIGNAL WAS MEASURABLE. A PART OF THE CABLE CAN BE SEEN THROUGH THE AUDITORY CANAL (THE PT HAS A RADICAL CAVITY). A REIMPLANTATION IS SCHEDULED FOR (B)(6), 2010.
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 | 47 YR |