FDA Adverse Event
Injury
Summary report: N
VIBRANT SOUNDBRIDGE
MDR report key: 3003892
·
Received March 12, 2013
Report
- Report Number
- 3004230826-2013-00021
- Event Type
- Injury
- Date Received
- March 12, 2013
- Report Date
- March 5, 2013
- Manufacturer
- VIBRANT MED-EL HEARING TECHNOLOGY GMBH
- Product Code
- MPV
- PMA / PMN Number
- P990052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(6) WHERE IT WILL BE EVALUATED. WHERE AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.
Description of Event or Problem · 1
THE EXPLANTED VORP 39920 WAS RECEIVED AT MED-EL HEADQUARTERS ON (B)(6) 2013. TO DATE NO FURTHER INFO HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102987 | VIBRANT SOUNDBRIDGE | VORP | MPV | VIBRANT MED-EL HEARING TECHNOLOGY GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |