BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2870104 · Received December 12, 2012

    Report

    Report Number
    6000034-2012-02318
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS TREATED FOR PAIN AT THE IMPLANT SITE WITH OCCIPITAL NERVE BLOCK INJECTIONS ON (B)(6) 2012 AND AGAIN ON (B)(6) 2012. AS OF THE DATE OF THIS REPORT, (B)(6) 2012, THE TREATMENT HAS NOT RESOLVED THE PAIN. THE IMPLANTED DEVICE REMAINS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention