BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 545291 · Received September 22, 2004

    Report

    Report Number
    2029203-2004-00186
    Event Type
    Injury
    Date Received
    September 22, 2004
    Date of Event
    August 1, 2004
    Report Date
    September 22, 2004
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING INITIAL IMPLANT SURGERY, THE PT REPORTEDLY HAD AN INCOMPLETE ELECTRODE ARRAY INSERTION WITH ONE ELECTRODE AT THE COCHLEAR IMPLANT. THE SURGEON NOTED THAT THE RECESS PREVIOUSLY PREPARED WAS USED AND A MORE INFERIOR COCHLEOSTOMY WAS FORMED. ALL ELECTRODES OF THE ARRAY WERE PLACED IN THE COCHLEA. INTRAOPERATIVE NRI RESULTS WERE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention