BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3811036 · Received March 24, 2014

    Report

    Report Number
    3006556115-2014-00116
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    April 3, 2012
    Report Date
    March 3, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT DEVELOPED SKIN FLAP NECROSIS AND HAD A SKIN FLAP REVISION ON (B)(6), 2012. THE PATIENT ALSO HAD TWO PLASTIC SURGERIES TO THE SKIN FLAP AREA WITHOUT RESOLVE. HYPERBARIC THERAPY WAS ATTEMPTED, HOWEVER THIS DID NOT RESOLVE THE ISSUE. IN (B)(6) OF 2013 THE PATIENT PRESENTED WITH "PSEOMONAS" INFECTION. THE PATIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. ONCE ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173371 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention