FDA Adverse Event
Injury
Summary report: N
VIBRANT SOUNDBRIDGE
MDR report key: 3011135
·
Received March 15, 2013
Report
- Report Number
- 3004230826-2013-00024
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 8, 2013
- 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 SHOULD 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 WAS IMPLANTED AFTER A CAR CRASH. THE DEVICE WAS WORKING AND THE PATIENT WAS SATISFIED. THE PATIENT HAD ANOTHER TRAUMA ON HIS HEAD AND NO LONGER BENEFITED FROM THE DEVICE. THE SURGEON DECIDED TO EXPLANT THE VSB AND IMPLANT A CI ON THE SAME SIDE. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110850 | VIBRANT SOUNDBRIDGE | VORP | MPV | VIBRANT MED-EL HEARING TECHNOLOGY GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |