BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 220031 · Received April 22, 1999

    Report

    Report Number
    6000034-1999-00055
    Event Type
    Injury
    Date Received
    April 22, 1999
    Date of Event
    October 5, 1998
    Report Date
    April 21, 1999
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PER THE HEALTH CARE PROFESSIONAL, THE ELECTRODE ARRAY OF THE IMPLANT INADVERTENTLY WAS PLACED OUTSIDE OF THE COCHLEAR. EXPLANTATION/REIMPLANTATION SURGERY WAS SCHEDULED FOR 04/05/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM Implant 24 CHANNEL COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention