FDA Adverse Event
Injury
Summary report: N
VIBRANT SURROUNDINGS
MDR report key: 3961605
·
Received June 16, 2014
Report
- Report Number
- 3004230826-2014-00061
- Event Type
- Injury
- Date Received
- June 16, 2014
- Date of Event
- June 4, 2014
- Report Date
- July 8, 2014
- 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 THE MANUFACTURER 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
IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT BENEFIT DUE TO A MEDICAL PROBLEM AND THAT THE DEVICE WAS EXPLANTED. DURING EXPLANTATION, EXCESSIVE TISSUE GROWTH AND INFECTION WAS FOUND IN THE MIDDLE EAR. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353259 | VIBRANT SURROUNDINGS | VORP | MPV | VIBRANT MED-EL HEARING TECHNOLOGY GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |