BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR OSIA OSI200 IMPLANT

    MDR report key: 17593600 · Received August 22, 2023

    Report

    Report Number
    6000034-2023-02700
    Event Type
    Injury
    Date Received
    August 22, 2023
    Report Date
    September 15, 2023
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    UDI-DI
    09321502046152
    PMA / PMN Number
    K190589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON AUGUST 22, 2023.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON SEPTEMBER 22, 2023.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE ACTUATOR THROUGH THE INCISION SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS HOWEVER, THE SYMPTOMS DID NOT RESOLVE. THE DEVICE WAS EXPLANTED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801278 COCHLEAR OSIA OSI200 IMPLANT NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED OSI200 NA 09321502046152
    2340036 COCHLEAR OSIA OSI200 IMPLANT NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED OSI200 NA 09321502046152

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention