BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1343210 · Received March 11, 2009

    Report

    Report Number
    3006556115-2009-00144
    Event Type
    Injury
    Date Received
    March 11, 2009
    Date of Event
    June 15, 2004
    Report Date
    March 9, 2009
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE COMPANY WAS INFORMED THAT FOLLOWING THE SURGERY IN 2004, NO OBVIOUS INFECTION OR CELLULITIS WAS OBSERVED. THE COMPANY WAS FURTHER INFORMED THAT THE PATIENT'S IMPLANT SITE GOT INFECTED AND THE PATIENT'S DEVICE WAS SUBSEQUENTLY REMOVED AS REPORTED IN THE REFERENCED MDR. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING THE REVIEW OF THE PATIENT'S MEDICAL RECORDS PROVIDED BY LEGAL, THE COMPANY WAS INFORMED THAT FOLLOWING THE IMPLANT SURGERY, THE PATIENT HAD DEVELOPED A 2CM DEHISCENCE IN THE SUPERIOR ASPECT OF POST AURICULAR INCISION. THE PATIENTS DOCTOR PRESUMED THAT IT WAS DUE TO "A FAILURE OF A SUTURE". IN 2004, THE SUTURE WAS REPLACED AND THE PATIENT WAS PRESCRIBED KEFLEX. THE FOLLOWING MONTH, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR WOUND INCISION AND DRAINAGE WITH DEBRIDEMENT AND CLOSURE UTILIZING A PREAURICULAR ADEQUATE FLAP. DURING THE SURGERY. THE DOCTOR DID NOT OBSERVE ANY EVIDENCE OF ACTIVE INFECTION, HOWEVER, THE SKIN EDGES OF THE POSTAURICULAR INCISION WERE VERY DARK AND NECROTIC AND HAD TO BE EXCISED. THE PATIENT WAS PRESCRIBED BACITRACIN FOR THE WOUND CARE AND TYLENOL #3. THE PATIENT WAS ALSO RECOMMENDED TO CLEAN THE WOUND WITH PEROXIDE. IN THE SAME MONTH. THE PATIENT HAD PRE-AURICULAR INFERIORLY BASED FLAP ROTATED TO THE POST AURICULAR SULCUS FOR RECONSTRUCTION TO ENHANCE THE WOUND CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R