BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 1475090 · Received June 18, 2009

    Report

    Report Number
    3004230826-2009-00030
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    January 1, 2001
    Report Date
    June 18, 2009
    Manufacturer
    VIBRANT MED-EL HEARING TECHNOLOGY GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 FOLLOW UP REPORT. THIS DEVICE HAS BEEN MANUFACTURED BY SYMPHONIX CORP. VIBRANT MED-EL TOOK OVER THE ASSETS FROM SYMPHONIX CORP IN 2003. AS SUCH VIBRANT MED-EL FEELS RESPONSIBLE TO FOLLOW-UP ON PRODUCT PROBLEMS WITH SYMPHONIX PRODUCED DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BEEN HAPPY USING THE DEVICE SINCE IMPLANTATION IN THE LEFT EAR ON (B) (6) 1997. ON (B) (6) 2001, THE PT NOTICED NO OUTPUT FROM THE DEVICE. SHE ATTENDED THE CLINIC AT THAT TIME, WHERE ANY POSSIBLE PROBLEM WITH THE AUDIO PROCESSOR WAS EXCLUDED. SHE WOULD LIKE TO REGAIN THE GOOD PERFORMANCE PREVIOUSLY ATTAINED WITH HER SOUNDBRIDGE AND IS NOW PREPARED TO UNDERGO REIMPLANTATION. SO FAR NO DATE HAS BEEN SCHEDULED.

    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