BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2981491 · Received February 27, 2013

    Report

    Report Number
    6000034-2013-00315
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PATIENT HAS NOT BEEN REIMPLANTED WITH A NEW DEVICE, AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT'S DEVICE HAD EXTRUDED THROUGH THE SKIN, EXPOSING THE RECEIVER/STIMULATOR. THE DEVICE WAS EXPLANTED (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85495 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention