BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 210403 · Received February 17, 1999

    Report

    Report Number
    6000034-1999-00018
    Event Type
    Malfunction
    Date Received
    February 17, 1999
    Report Date
    February 17, 1999
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED HEARING INTERMITTENT SOUND SENSATIONS. USING THE APPROPRIATE DIAGNOSTIC EQUIPMENT, IT WAS DETERMINED THAT THE DEVICE IS NOT FUNCTIONING ACCORDING TO MANUFACTURER'S SPECIFICATIONS. EXPLANTATION/REIMPLANTATION SURGERY HAS BEEN SCHEDULED FOR 02/25/1999.

    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 68 YR