BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR OSIA OSI100 IMPLANT

    MDR report key: 10151653 · Received June 14, 2020

    Report

    Report Number
    6000034-2020-01504
    Event Type
    Injury
    Date Received
    June 14, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 22, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    PFO
    UDI-DI
    09321502046152
    PMA / PMN Number
    K190589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUNE 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR EXTERNAL MAGNET RETENTION. THE PATIENT HAD A SKIN-FLAP REVISION SURGERY ON (B)(6) 2020 UNDER A GENERAL ANAESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615288 COCHLEAR OSIA OSI100 IMPLANT NUCLEUS 24 COCHLEAR IMPLANT SYSTEM PFO COCHLEAR LTD OSI200 NA 09321502046152

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention