BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS HYBRID L24

    MDR report key: 6933659 · Received October 10, 2017

    Report

    Report Number
    6000034-2017-01895
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 28, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    UDI-DI
    09321502012089
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON OCTOBER 10, 2017, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND A PERFORMANCE DECREMENT RESULTING IN THE DECISION TO EXPLANT THE DEVICE ON (B)(6) 2017. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715870 NUCLEUS HYBRID L24 NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LTD CI24RE (L24) NA 09321502012089

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention