BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 4862720 · Received June 23, 2015

    Report

    Report Number
    6000034-2015-01109
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    May 30, 2015
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE RECHARGEABLE BATTERY WAS "HOT" TO THE TOUCH AND REPORTEDLY "BURNED" THE MOTHERS SKIN. THE PATIENT WAS ADVISED TO DISCONTINUE USE OF THE BATTERY AND A NEW REPLACEMENT BATTERY WAS SENT. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404935 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD . CP800 ACC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention