BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR OSIA OSI300 IMPLANT

    MDR report key: 18510079 · Received January 15, 2024

    Report

    Report Number
    6000034-2024-00191
    Event Type
    Injury
    Date Received
    January 15, 2024
    Report Date
    March 1, 2024
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    PFO
    UDI-DI
    09321502070676
    PMA / PMN Number
    K231204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CORRECT COMMON DEVICE NAME AND PMA/510(K) IS COCHLEAR¿ OSIA¿ SYSTEM AND K231204 RESPECTIVELY; NOT NUCLEUS 24 COCHLEAR IMPLANT SYSTEM AND P970051 AS PREVIOUSLY REPORTED. PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. THIS REPORT IS SUBMITTED ON FEBRUARY 07, 2024.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS REPORT ATTACHED. THIS REPORT IS SUBMITTED ON MARCH 26, 2024.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JANUARY 15, 2024.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2023, FOR UNSPECIFIC MEDICAL REASONS. THE PATIENT HAS NOT BEEN REIMPLANTED WITH A NEW DEVICE AS OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369722 COCHLEAR OSIA OSI300 IMPLANT COCHLEAR¿ OSIA¿ SYSTEM PFO COCHLEAR LIMITED OSI300 NA 09321502070676
    639278 COCHLEAR OSIA OSI300 IMPLANT COCHLEAR¿ OSIA¿ SYSTEM PFO COCHLEAR LIMITED OSI300 NA 09321502070676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention