BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 375001 · Received February 1, 2002

    Report

    Report Number
    2029203-2001-00105
    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, PATIENT WAS SEEN BY THE IMPLANT SURGEON BECAUSE THE SKIN FLAP HAD NOT HEALED PROPERLY. AT THAT TIME, IT WAS DISCOVERED THAT THE DEVICE WAS EXTRUDING AND THE ELECTRODE ARRAY WAS LAYING IN THE WRONG LOCATION. THE PATIENT WAS REPORTEDLY STARTED ON ANTIBIOTICS. THE FOLLOWING MONTH, THE PATIENT WENT TO SEE THE REPORTING SURGEON SINCE THE CONDITION HAD NOT IMPROVED. IT WAS DETERMINED THAT THE DEVICE SHOULD BE EXPLANTED AND THE PATIENT NOT BE REIMPLANTED. EXPLANT SURGERY WAS PERFORMED ON THE SAME MONTH. THE REPORTING SURGEON INDICATED THAT THIS PATIENT SHOULD HAVE NOT BEEN A COCHLEAR IMPLANT CANDIDATE DUE TO THEIR MEDICAL CONDITION AND HISTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention