BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 375983 · Received February 11, 2002

    Report

    Report Number
    2029203-2002-00040
    Event Type
    Injury
    Date Received
    February 11, 2002
    Date of Event
    January 8, 2002
    Report Date
    February 8, 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
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED NO SOUND PERCEPT USING THE DEVICE. THE PT WAS SEEN AT IMPLANT CENTER FOR DEVICE EVALUATION. UPON REVIEW OF THE X-RAY, THE SURGEON OBSERVED THAT THE ELECTRODE ARRAY WAS NOT IN THE COCHLEA CORRECTLY. REVISION SURGERY WAS SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention