FDA Adverse Event
Injury
Summary report: N
VIBRANT SOUNDBRIDG
MDR report key: 3987398
·
Received July 23, 2014
Report
- Report Number
- 3004230826-2014-00069
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- June 5, 2014
- Report Date
- July 16, 2014
- Manufacturer
- VIBRANT MED-EL HEARING TECHNOLOGY GMBH
- Product Code
- MPV
- PMA / PMN Number
- P990052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 ACCORDING TO THE SURGEON THE DEVICE WAS NOT WORKING. HOWEVER, IN SITU TESTING WAS INDICATIVE OF A FUNCTIONAL DEVICE. IT WAS ASSUMED THAT THE FLOATING MASS TRANSDUCER HAD DISLODGED FROM THE ROUND WINDOW. THE PATIENT WAS EXPLANTED OF THE DEVICE ON (B)(6), 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432514 | VIBRANT SOUNDBRIDG | VORP | MPV | VIBRANT MED-EL HEARING TECHNOLOGY GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |