BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE DIRECT SYSTEM

    MDR report key: 499560 · Received December 6, 2003

    Report

    Report Number
    1651971-2003-00001
    Event Type
    Malfunction
    Date Received
    December 6, 2003
    Date of Event
    October 21, 2003
    Report Date
    November 21, 2003
    Manufacturer
    SOUNDTEC, INC.
    Product Code
    ESD
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED AT THE REQUEST OF THE SUBJECT DUE TO PERCEIVED "SCRATCHY AND RATTLING" NOISE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT IT MET ALL DEVICE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE DIRECT SYSTEM MIDDLE EAR IMPLANT ESD SOUNDTEC, INC. 300-0039-001 1527

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other