BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 14285103 · Received May 5, 2022

    Report

    Report Number
    6000034-2022-01239
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Report Date
    May 16, 2022
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON MAY 04, 2022.

    Additional Manufacturer Narrative · 0

    CORRECTION:THE DATE OF BIRTH (B2) WAS FILED INADVERTENTLY IN THE PREVIOUS REPORT, THE CORRECT DATE SHOULD BE APRIL 01, 1943. PER THE CLINIC, THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE DISLODGED MAGNET (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS. THIS REPORT IS SUBMITTED ON JUNE 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND MAGNET DISLODGEMENT (SPECIFIC DATE NOT REPORTED). SURGERY TO REPLACE THE MAGNET IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT. THE IMPLANTED DEVICE REMAINS. 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
    1592906 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LIMITED CI512 NA 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R