BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2862365 · Received December 10, 2012

    Report

    Report Number
    6000034-2012-02314
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    September 10, 2013
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED OCTOBER 10, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT SUSTAINED A FALL RESULTING IN INJURY TO THE HEAD, (DATE NOT REPORTED). THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS FOLLOWING THE EVENT FOR OBSERVATION. PATIENT REPORTS "SHOCK AND PAIN" WITH STIMULATION, LEADING TO DEVICE NON-USE. THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE, HOWEVER IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R