BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22

    MDR report key: 6448732 · Received March 31, 2017

    Report

    Report Number
    6000034-2017-00648
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 13, 2017
    Report Date
    May 15, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P840024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED JUNE 02, 2017.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE. SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2017 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231668 NUCLEUS 22 NUCLEUS 22 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention