BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM

    MDR report key: 5948334 · Received September 13, 2016

    Report

    Report Number
    6000034-2016-01768
    Event Type
    Injury
    Date Received
    September 13, 2016
    Report Date
    September 15, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    PGQ
    UDI-DI
    09321502012089
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. PER THE CLINIC, THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR REDNESS OVER THE IMPLANT SITE (DATE NOT REPORTED). THIS REPORT IS FILED OCTOBER 10, 2016. H3 OTHER TEXT: IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FILED ON SEPTEMBER 14, 2016. THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818. EXEMPTION NUMBER E2016011. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED PAIN AND DIZZINESS, HOWEVER THE ISSUE DID NOT RESOLVE. SUBSEQUENTLY THE PATIENT WAS TREATED WITH ORAL STEROIDS (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599594 NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM PGQ PGQ COCHLEAR LTD CI24RE (L24) NA 09321502012089

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention