BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2991435 · Received March 6, 2013

    Report

    Report Number
    6000034-2013-00367
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 22, 2013
    Report Date
    November 6, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON OCTOBER 10, 2013. THIS REPORT IS FILED DECEMBER 12, 2013.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON JULY 3, 2013. THIS REPORT IS FILED OCTOBER 16, 2013.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE PATIENT UNDERWENT A SECOND PROCEDURE ON (B)(6), 2013, TO TREAT INFECTED AREA AROUND THE IMPLANTED SITE. AN INCISION WAS MADE AND THE SITE WAS DRAINED. IT WAS REPORTED THAT THE INFECTION HAS RESOLVED AND THE PATIENT IS SUCCESSFULLY USING THE DEVICE.THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED (B)(4), 2013. (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED PAIN AROUND THE IMPLANT SITE IN (B)(6) 2012 (EXACT DATE NOT REPORTED) THOUGHT TO BE CAUSED BY A SINUS INFECTION. THE PATIENT WAS PRESCRIBED AMOXICILLIN, TWICE A DAY FOR A TWO WEEK COURSE. PATIENT SYMPTOMS DID NOT RESOLVE. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS PLACED ON A THREE WEEK COURSE OF AUGMENTIN (AMOUNT NOT REPORTED). ON (B)(6) 2013, IT WAS REPORTED THAT THE SITE WAS DIFFUSELY EDEMATOUS AND PATIENT STILL REPORTED PAIN. THE PATIENT WAS THEN SEEN AGAIN ON (B)(6) 2013, AT WHICH TIME WAS TAKEN INTO THE OPERATING ROOM FOR AN EXPLORATION OF THE IMPLANT SITE AND PLACEMENT OF A PICC LINE FOR IV ANTIBIOTIC TREATMENT WITH CEFTRIAXONE, PATIENT WAS ALSO PRESCRIBED ORAL CLINDAMYCIN. PATIENT WAS ADMITTED TO THE HOSPITAL POST OPERATIVELY (LENGTH OF STAY NOT REPORTED). ON (B)(6) 2013, THE IV ANTIBIOTIC WAS CHANGED TO ANTIBIOTIC VANCOMYCIN, THE PATIENT DEVELOPED AN ALLERGIC REACTION AND WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. PATIENT WAS DISCHARGED ON (B)(6) 2013. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95656 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R