FDA Adverse Event
Injury
Summary report: N
VIBRANT SOUNDBRIDGE
MDR report key: 3840999
·
Received May 14, 2014
Report
- Report Number
- 3004230826-2014-00046
- Event Type
- Injury
- Date Received
- May 14, 2014
- Report Date
- April 27, 2014
- Manufacturer
- VIBRANT MED-EL HEARING TECHNOLOGY GMBH
- Product Code
- MPV
- PMA / PMN Number
- P990052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.
Description of Event or Problem · 1
THE CONCERN DEVICE WAS EXPLANTED. SO FAR NO INFO HAS BEEN RECEIVED REGARDING THE CIRCUMSTANCES WHICH LET TO THE DEVICE EXPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287948 | VIBRANT SOUNDBRIDGE | VORP | MPV | VIBRANT MED-EL HEARING TECHNOLOGY GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |