BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS® HYBRID¿ S8

    MDR report key: 12679176 · Received October 22, 2021

    Report

    Report Number
    6000034-2021-03192
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    September 28, 2021
    Report Date
    November 2, 2021
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    PGQ
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS REPORT IS ATTACHED. THIS REPORT IS SUBMITTED ON NOVEMBER 22, 2021.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON OCT 22, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2021. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582804 NUCLEUS® HYBRID¿ S8 NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM PGQ COCHLEAR LIMITED CI24RE (S8) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention