BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 3213983 · Received July 9, 2013

    Report

    Report Number
    6000034-2013-01202
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 26, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTEDLY DISCONTINUED USE OF THE DEVICE IN (B)(6) 2013 (SPECIFIC DATE NOT REPORTED), SUBSEQUENT TO POOR SOUND QUALITY. THE IMPLANTED DEVICE REMAINS. THERE ARE NO PLANS TO EXPLANT THE DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312740 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention