BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM

    MDR report key: 6095071 · Received November 11, 2016

    Report

    Report Number
    6000034-2016-02246
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 21, 2016
    Report Date
    December 14, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    PGQ
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FILED ON NOVEMBER 11, 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 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED JANUARY 13, 2017.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT INITIAL "DATE OF THIS REPORT" IS 10/28/2016, NOT 10/31/2016, AS INITIALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747211 NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM PGQ PGQ COCHLEAR LTD. CI24RE (L24) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention