BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2902350 · Received January 8, 2013

    Report

    Report Number
    6000034-2013-00049
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 28, 2012
    Report Date
    April 2, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE PATIENT WAS SEEN ON (B)(6) 2012 FOR REPORTS OF PAIN, SWELLING, AND DRAINAGE AROUND THE INCISION SITE. AT THE TIME OF THE VISIT, IT WAS REPORTED THAT THE PATIENT HAD A WOUND INFECTION WITH MILD ERYTHEMA. A PUSTULE WAS OPENED AND DRAINED AND A SMALL AREA OF WOUND DEHISCENCE WAS CLOSED. THE PATIENT WAS PRESCRIBED KEFLEX 500MG FOR TEN DAYS AND WOUND CARE WITH BACITRACIN OINTMENT. ON (B)(6) 2012, THE PATIENT REPORTED AN INCREASE IN DRAINAGE AND THE ANTIBIOTIC WAS CHANGED TO AUGMENTIN AND WOUND CARE WITH BACTROBAN OINTMENT. CORRECTION: POST EXPLANTATION AND DISMISSAL FROM THE HOSPITAL, THE PATIENT RECEIVED TWO WEEKS OF HOME IV ANTIBIOTIC THERAPY. CORRECTION: THE CORRECT DATE OF EVENT IS (B)(6) 2012; NOT (B)(6) 2013 AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT DATE OF THE REPORT IS (B)(4) 2013; NOT (B)(4) 2013 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2013 DUE TO INFECTION. POST EXPLANTATION, THE PATIENT WAS HOSPITALIZED FOR IV ANTIBIOTIC TREATMENT. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS FOR TWO WEEKS. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE, HOWEVER IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9036 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R