BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 6128268 · Received November 27, 2016

    Report

    Report Number
    6000034-2016-02393
    Event Type
    Injury
    Date Received
    November 27, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 20, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 28, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4) REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. H3 OTHER TEXT: DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2016 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778823 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention