BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM

    MDR report key: 5835934 · Received August 1, 2016

    Report

    Report Number
    6000034-2016-01563
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 18, 2018
    Manufacturer
    COCHLEAR LTD.
    Product Code
    PGQ
    PMA / PMN Number
    P130016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. THIS REPORT IS FILED AUGUST 29, 2016. (B)(4).

    Additional Manufacturer Narrative · 0

    REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. THIS REPORT IS FILED ON AUGUST 01, 2016. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE, HOWEVER THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2016 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT 'BRAND NAME' IS NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM, NOT NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT PMA NUMBER IS P130016, NOT P970051 AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490222 NUCLEUS 24 CHANNEL HYBRID COCHLEAR IMPLANT SYSTEM PGQ PGQ COCHLEAR LTD. CI24RE (L24) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention