BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CONTOUR

    MDR report key: 13068768 · Received December 22, 2021

    Report

    Report Number
    6000034-2021-04077
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    June 30, 2010
    Report Date
    November 29, 2021
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON DECEMBER 23, 2021.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2010 (REASON UNKNOWN). THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. FURTHER INFORMATION IS BEING SOUGHT FROM THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960277 NUCLEUS 24 CONTOUR NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention