BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1812519 · Received August 10, 2010

    Report

    Report Number
    3004230826-2010-00034
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Report Date
    July 30, 2010
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(4) 2010, THE PT REPORTED THAT HER HUSBAND'S VOICE HAD AN "ECHO" QUALITY TO IT. IN (B)(4) 2010, SHE BEGAN COMPLAINING OF FEEDBACK (WHISTLING) FROM THE DEVICE. TROUBLESHOOTING AT THE CLINIC RESULTED IN THE REPLACEMENT OF THE ORIGINAL AUDIO PROCESSOR. UPON USING THE REPLACEMENT AUDIO PROCESSOR FOR THE FIRST TIME, THE PT REPORTED STATIC AND THEN NO SOUND. THE AUDIOLOGIST ATTEMPTED TROUBLESHOOTING. BOTH THE ORIGINAL AND REPLACEMENT AUDIO PROCESSORS WERE FUNCTIONING CORRECTLY. THE PT DENIES TRAUMA TO THE HEAD. NO PAIN WAS REPORTED. SHE ALSO DENIES RECENT ILLNESS, INCLUDING A COLD OR ALLERGIES. SHE DID NOTE THAT SHE HAS EXPERIENCED FULLNESS IN HER EAR SINCE THE TIME OF IMPLANTATION IN (B)(4) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK