BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE

    MDR report key: 7305524 · Received March 1, 2018

    Report

    Report Number
    6000034-2018-00459
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    March 1, 2018
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032612
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 01, 2018, (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE DEVICE DUE TO A SUSPECTED ALLERGIC REACTION. EXPLANTATION IS PLANNED, BUT YET TO OCCUR AS OF THE DATE OF THIS REPORT MARCH 01, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149453 NUCLEUS CI532 COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI532 NA 09321502032612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention