BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2063489 · Received April 19, 2011

    Report

    Report Number
    6000034-2011-00274
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    August 9, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(6), 2011.

    Description of Event or Problem · 1

    PER THE CLINIC, THE ELECTRODE ARRAY WAS DAMAGED DURING SURGERY TO REVISE THE IMPLANT BED (DATE NOT REPORTED). THE DEVICE WAS EXPLANTED AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.

    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. CI24R (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention