BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1970581 · Received January 25, 2011

    Report

    Report Number
    6000034-2011-00048
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    November 29, 2010
    Report Date
    June 23, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED A PERFORMANCE DECREMENT AND PAIN WITH, AND WITHOUT, STIMULATION. ADDITIONALLY, THERE WAS EVIDENCE OF INFLAMMATION AT THE IMPLANT SITE. THE PATIENT WAS HOSPITALIZED (DATE UNKNOWN) AND TREATED WITH ORAL ANTIBIOTICS. THE DEVICE WAS EXPLANTED (B)(6), 2010, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24R (ST) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R