BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 374993 · Received February 1, 2002

    Report

    Report Number
    2029203-2002-00021
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    September 1, 2000
    Report Date
    January 31, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2000, APPROXIMATELY TWO WEEKS POST IMPLANT SURGERY, THE PATIENT DEVELOPED A FLAP BREAKDOWN WHICH LEAD TO AN INFECTION. THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE. THERE WERE NO REPORTS OF ICS PERFORMANCE PROBLEMS PRIOR TO DEVICE EXPLANTATION. DURING THE REVISION SURGERY, THE PHYSICIAN DECIDED TO LEAVE THE ELECTRODE ARRAY IN THE COCHLEA. IN 2001, THE PHYSICIAN SCHEDULED REVISION SURGERY DUE TO THE EXTRUSION OF THIS ELECTRODE ARRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION AB-5100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Required Intervention