BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1041139 · Received May 9, 2008

    Report

    Report Number
    6000034-2008-00237
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    March 5, 2008
    Report Date
    May 9, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT HAD A PERSISTENT SKIN FLAP INFECTION. SIX MONTHS OF TREATMENT WITH ANTIBIOTICS DID NOT RESOLVE THE PROBLEM. THE PT'S DEVICE WAS EXPLANTED IN 2008. REIMPLANTATION IS PLANNED IN APPROX THREE MONTHS, AFTER SKIN FLAP RECOVERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention