BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM

    MDR report key: 6062747 · Received October 27, 2016

    Report

    Report Number
    6000034-2016-02133
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 17, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF (B)(4). REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS FILED NOVEMBER 28, 2016. - ATTACHMENT: [62697-DEVICE ANALYSIS REPORT.PDF]

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FILED ON OCTOBER 28, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). REGISTRATION NUMBER 3009092818. 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. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713707 NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM PGQ PGQ COCHLEAR LTD CI24RE (L24) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention