BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 8725668 · Received June 23, 2019

    Report

    Report Number
    6000034-2019-01113
    Event Type
    Injury
    Date Received
    June 23, 2019
    Report Date
    July 11, 2019
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502014564
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JUNE 24, 2019, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE RECIPIENT WAS EXPERIENCING POOR SOUND QUALITY AND CHRONIC HEADACHE. THE RECIPIENT IS ESSENTIALLY A NON-USER AND NOW WOULD LIKE TO START WEARING HER PROCESSOR AGAIN. THE COCHLEAR IMPLANT WAS EVALUATED ON (B)(6) 2019 USING THE INTEGRITY TEST SYSTEM. THE RESULTS INDICATED NEITHER EVIDENCE OF MALFUNCTION OF THE RECEIVER/STIMULATOR NOR ELECTRODE FAULTS. THE IMPLANTED DEVICE REMAINS. CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON JUNE 24, 2019 WAS FILED INADVERTENTLY. NO DEVICE MALFUNCTION/ EXPLANTATION OR SERIOUS INJURY HAS OCCURRED.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED FOR AN UNKNOWN REASON ON AN UNKNOWN DATE. IT IS UNKNOWN IF THE PATIENT WAS RE-IMPLANTED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519200 NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM, MCM COCHLEAR LTD CI512 N/A 09321502014564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention