BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 5414071 · Received February 5, 2016

    Report

    Report Number
    6000034-2016-00224
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    January 15, 2016
    Report Date
    January 25, 2017
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON MARCH 07, 2017, BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. EXEMPTION NUMBER E2016011. (B)(4).

    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 MCM; NOT PGQ AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(6) 2016. THE DEVICE IS UNAVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED, FEBRUARY 5, 2016. THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED ABNORMAL PERCEPTS FOLLOWED BY NO SOUND. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71757 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM: PRODUCT CODE: MCM COCHLEAR LTD . CI24RE (ST)

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention