BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24

    MDR report key: 6423197 · Received March 21, 2017

    Report

    Report Number
    6000034-2017-00611
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    March 15, 2017
    Report Date
    April 28, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON MAY 22, 2017.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 22, 2017.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LACK OF CLINICAL BENEFIT WITH DEVICE USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2017. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203626 NUCLEUS 24 NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention