BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3103836 · Received May 10, 2013

    Report

    Report Number
    6000034-2013-00871
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 26, 2012
    Report Date
    March 26, 2012
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRY AND STORE UNIT WAS FOUND TO HAVE MELTED DUE TO ABNORMAL HEATING. NO SERIOUS INJURY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206673 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD SP ACCESSORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention