BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 4101734 · Received September 15, 2014

    Report

    Report Number
    3004230826-2014-00078
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    June 1, 2014
    Report Date
    August 26, 2014
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(4) 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 NO CONSISTENT AUDIOGRAM RESPONSE COULD BE OBTAINED WITH THE LEFT IMPLANT OF THE BILATERALLY IMPLANTED PATIENT. THE PATIENT HAD A COLD AND RECEIVED ANTIBIOTIC TREATMENT. A MIDDLE EAR CONGESTION COULD BE RESOLVED WITH A FURTHER COURSE OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570236 VIBRANT SOUNDBRIDGE VORP MPV VIBRANT MED-EL HEARING TECHNOLOGY GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention