BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1163133 · Received September 16, 2008

    Report

    Report Number
    6000034-2008-00531
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT REPORTEDLY HAS AN INFECTION AT THE IMPLANT SITE. THE PATIENT HAD EXPLANT SURGERY 2008. REIMPLANT SURGERY HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention