BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3103835 · Received May 10, 2013

    Report

    Report Number
    6000034-2013-00872
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    July 31, 2012
    Report Date
    August 3, 2012
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL DEVICE WARMED UP DURING THE INITIAL FITTING SESSION. NO SERIOUS INJURY HAS OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206162 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CP810

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention