BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 5498420 · Received February 22, 2005

    Report

    Report Number
    9710014-2005-00085
    Event Type
    Injury
    Date Received
    February 22, 2005
    Date of Event
    October 1, 2004
    Report Date
    February 22, 2005
    Manufacturer
    SYMPHONIX, INC. C/O VIBRANT MED-EL, HEARING TECHNOLOGY GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN (B)(6) 2004 FOR THE ACTIVATION OF THE EXTERNAL EQUIPMENT. AT THAT TIME, THE PATIENT DID NOT NOTICE ANYTHING AT ALL WITH THE IMPLANT. A FEW DAYS LATER, PATIENT COULD NOT HEAR ANYTHING AT ALL. PATIENT WENT TO VISIT THEIR ACOUSTICIAN TO HAVE THEIR AUDIO PROCESSOR CHECKED. THE ACOUSTICIAN FOUND THE AP TO BE FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MCM SYMPHONIX, INC. C/O VIBRANT MED-EL, HEARING TECHNOLOGY GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention