BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3984137 · Received August 6, 2014

    Report

    Report Number
    6000034-2014-01134
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 14, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A SORE AT THE IMPLANT SITE THAT WAS ASPIRATED IN (B)(6) 2014 (SPECIFIC DATE NOT REPORTED). IN EARLY (B)(6) 2014 (SPECIFIC DATE NOT REPORTED) THE SITE WAS STILL WEEPING AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS (DATE NOT REPORTED). IN MID (B)(6) (SPECIFIC DATE NOT REPORTED) THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR IV ANTIBIOTICS AS THE ISSUE HAD NOT RESOLVED. IN LATE (B)(6) (SPECIFIC DATE NOT REPORTED) THE PATIENT UNDERWENT WOUND DEBRIDEMENT AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED (B)(6), 2014 AND THE PATIENT WAS IMPLANTED WITH A NEW DEVICE ON THE CONTRALATERAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460214 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI422

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Required Intervention