BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 244944 · Received October 15, 1999

    Report

    Report Number
    6000034-1999-00133
    Event Type
    Malfunction
    Date Received
    October 15, 1999
    Date of Event
    September 9, 1999
    Report Date
    October 15, 1999
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT STOPPED RESPONDING TO SOUND AFTER HITTING HER HEAD OVER THE IMPLANT SITE. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MFR'S SPECS. EXPLANATION/REIMPLANTATION SURGERY WAS DONE ON 10/01/1999. THE HEALTHCARE PROFESSIONAL HAS BEEN INFORMED THAT THE IMPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR LIMITED.

    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 9 YR