BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE

    MDR report key: 8761548 · Received July 3, 2019

    Report

    Report Number
    6000034-2019-01108
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 14, 2019
    Report Date
    July 30, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032612
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED AUGUST 26, 2019.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 04, 2019 BY COCHLEAR LIMITED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED ON (B)(6) 2019. PER THE CLINIC, THE RECIPIENT DID NOT RECEIVE ANY BENEFIT FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554977 NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI532 NA 09321502032612

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention