BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2905851 · Received January 10, 2013

    Report

    Report Number
    6000034-2013-00067
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 29, 2012
    Report Date
    March 28, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE IMPLANT SIDE. TREATMENT WITH ANTIBIOTICS (TYPE NOT REPORTED) WAS UNSUCCESSFUL. THE DEVICE WAS EXPLANTED ON (B)(6) 2012, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON THE CONTRALATERAL SIDE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15417 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (ST)

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention