BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 5448599 · Received February 19, 2016

    Report

    Report Number
    6000034-2016-00269
    Event Type
    Injury
    Date Received
    February 19, 2016
    Report Date
    February 3, 2017
    Manufacturer
    COCHLEAR LTD .
    Product Code
    PGQ
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, IT WAS REPORTED THERE WAS AN INFECTION AT IMPLANT SITE (DATE NOT REPORTED). THIS REPORT IS FILED ON FEBRUARY 17, 2017 BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. EXEMPTION NUMBER E2016011.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2016; DURING THE SAME SURGERY THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE. CORRECTION: THE CORRECT COMMON DEVICE NAME IS PGQ; NOT MCM AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(6) 2016. THE DEVICE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED FEBRUARY 18, 2016. THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED NON AUDITORY PAIN/SENSATION WITH AND WITHOUT DEVICE USE AS WELL AS POOR SOUND QUALITY. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS AT THIS TIME. HOWEVER, EXPLANT AND REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT, FEBRUARY 18, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104763 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. PGQ: PRODUCT CODE: PGQ COCHLEAR LTD . CI24RE (L24)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention