BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1912046 · Received December 1, 2010

    Report

    Report Number
    6000034-2010-00745
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 17, 2010
    Report Date
    June 15, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2010; DURING THE SAME SURGERY THE PATIENT WAS IMPLANTED WITH ANOTHER DEVICE.THIS REPORT IS FILED (B)(6), 2011.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING WAS ATTEMPTED, BUT DID NOT ALLEVIATE THE PROBLEM. EXPLANT AND REIMPLANTATION IS PLANNED, BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2010.

    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. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention