BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2945706 · Received February 6, 2013

    Report

    Report Number
    6000034-2013-00193
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 17, 2012
    Report Date
    May 31, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION: PER THE CLINIC, THE PATIENT WAS IMPLANTED IN THE CONTRALATERAL EAR DURING THE REVISION SURGERY PERFORMED (B)(6) 2012; NOT REIMPLANTED IN THE SAME EAR AS PREVIOUSLY REPORTED. PER THE CLINIC, THE PATIENT WAS PRESCRIBED A 30-DAY COURSE OF AUGMENTIN (DOSAGE NOT REPORTED) ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE DEVICE (DATE AND SPECIFIC DETAILS NOT REPORTED). THE DEVICE WAS EXPLANTED (B)(6) 2012, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51294 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention