BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 8410596 · Received March 11, 2019

    Report

    Report Number
    6000034-2019-00394
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 22, 2019
    Report Date
    August 13, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032643
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL: IT HAS SINCE BEEN REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2019 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS SUBMITTED ON MAY 16, 2019.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED SEPTEMBER 03, 2019. - ATTACHMENT: [142421 DEVICE ANALYSIS REPORT.PDF].

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203167 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (ST) N/A 09321502032643

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Required Intervention