FDA Adverse Event
Injury
Summary report: N
VIBRANT SOUNDBRIDGE
MDR report key: 4023482
·
Received August 13, 2014
Report
- Report Number
- 3004230826-2014-00074
- Event Type
- Injury
- Date Received
- August 13, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 7, 2014
- Manufacturer
- VIBRANT MED-EL HEARING TECHNOLOGY GMBH
- Product Code
- MPV
- PMA / PMN Number
- P990052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 THE PATIENT WAS NOT HAVING BENEFIT FROM THE DEVICE SINCE ONE YEAR AGO. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2014, AND IN SITU TESTING PERFORMED THEN SHOWED THAT THE DEVICE HAD MALFUNCTIONED. THE PATIENT WAS EXPLANTED FROM THE DEVICE AND RE-IMPLANTED WITH A NEW VIBRANT SOUNDBRIDGE DURING THIS REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482963 | VIBRANT SOUNDBRIDGE | VORP | MPV | VIBRANT MED-EL HEARING TECHNOLOGY GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |