BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3081940 · Received April 29, 2013

    Report

    Report Number
    6000034-2013-00748
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    August 30, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN FLAP NECROSIS WITH EXPOSURE OF THE IMPLANTED DEVICE RESULTING IN THE DECISION TO EXPLANT THE DEVICE.THE DEVICE WAS EXPLANTED ON (B)(6), 2013, AND REIMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183261 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (ST)

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention