BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1060484 · Received June 13, 2008

    Report

    Report Number
    6000034-2008-00319
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    February 10, 2010
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    PER THE SURGEON'S REPORT IN 2008, THERE WAS SWELLING AND FLUID OVER THE PATIENT'S STIMULATOR/RECEIVER. THE PATIENT WAS UNABLE TO KEEP THE COIL/CABLE IN PLACE OVER THE MAGNET. SEVEN CC'S OF OLD BLOOD WERE ASPIRATED FROM THE SITE AND THEN A TREATMENT OF ANTIBIOTICS WAS STARTED. APPROXIMATELY ONE WEEK LATER, THE SWELLING AND FLUID OCCURRED AGAIN. THE SURGEON ASPIRATED 4CC'S OF BLOOD AND THE PATIENT CONTINUED WITH THE ANTIBIOTICS. THE PATIENT'S DAD CALLED TWO DAYS LATER TO REPORT THAT THE SITE APPEARED TO BE RE-SWELLING, BUT WITHIN TWO ADDITIONAL DAYS THE SITE HAD RETURNED TO NORMAL. THE SWOLLEN AREA HEALED AND THE PATIENT IS SUCCESSFULLY USING THE COCHLEAR DEVICE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: PT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH HER USE OF DEFECTIVE PRODUCT, THE BARD VENTRALEX HERNIA PATCH AND THE BARD KUGEL HERNIA PATCH. SPECIFICALLY, AS A RESULT OF HAVING THE BARD VENTRALEX HERNIA AND THE BARD KUGEL HERNIA PATCHES IMPLANTED IN PT, PT SUFFERED DISABLING PAIN AND REQUIRED SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention